Intervention Review

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Interventions for impetigo

  1. Sander Koning1,
  2. Renske van der Sande1,
  3. Arianne P Verhagen1,
  4. Lisette WA van Suijlekom-Smit2,
  5. Andrew D Morris3,
  6. Christopher C Butler4,
  7. Marjolein Berger1,5,
  8. Johannes C van der Wouden1,*

Editorial Group: Cochrane Skin Group

Published Online: 18 JAN 2012

Assessed as up-to-date: 27 JUL 2010

DOI: 10.1002/14651858.CD003261.pub3


How to Cite

Koning S, van der Sande R, Verhagen AP, van Suijlekom-Smit LWA, Morris AD, Butler CC, Berger M, van der Wouden JC. Interventions for impetigo. Cochrane Database of Systematic Reviews 2012, Issue 1. Art. No.: CD003261. DOI: 10.1002/14651858.CD003261.pub3.

Author Information

  1. 1

    Erasmus Medical Center, Department of General Practice, Rotterdam, Netherlands

  2. 2

    Erasmus MC - Sophia Children's Hospital, Department of Paediatrics, Paediatric Rheumatology, Rotterdam, Netherlands

  3. 3

    University of Wales College of Medicine, Department of Dermatology, Cardiff, Wales, UK

  4. 4

    University of Oxford, Nuffield Department of Primary Care Health Sciences, Oxford, UK

  5. 5

    University Medical Centre Groningen, Department of General Practice, Groningen, Netherlands

*Johannes C van der Wouden, Department of General Practice and Elderly Care Medicine, EMGO Institute for Health and Care Research, VU University Medical Center, PO Box 7057, Amsterdam, 1007 MB, Netherlands. j.vanderwouden@vumc.nl.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 18 JAN 2012

SEARCH

 
Characteristics of included studies [ordered by study ID]
Arata 1989a

MethodsTime NR; Japan; range of infections (impetigo 13/265)


Participants
  • Age 15 to 82 years
  • M/F 150/115 (all participants)
  • Mainly S.aureus


InterventionsA: cefdinir 100 mg, 3 td
B: cefaclor 250 mg, 3 td


OutcomesOutcomes of the trial

1) 10 days, excellent/good/poor


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available in the abstract.

Allocation concealment (selection bias)Unclear riskInsufficient information was available in the abstract.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "....double-blind."

Comment: There was unclear blinding of the outcome assessor and caregiver. The participant was probably blinded (see also Figure 2). The test drug packages also included placebo capsules.

Incomplete outcome data (attrition bias)
All outcomes
Low risk35/300 participants were omitted in the analysis: 16/147 in the cefdinir group (8 due to no or delayed visit to hospital, others for several reasons), 19/153 in the cefaclor group (8 due to no or delayed visit to hospital, others for several reasons) (see table 2).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was no baseline imbalance.

Randomised?Unclear riskInsufficient information was available in the abstract.

Were both inclusion and exclusion criteria specified?Unclear riskInsufficient information was available in the abstract.

Arata 1989b

MethodsTime NR; Japan; range of skin infections (including impetigo 18/259)


Participants
  • All ages
  • M/F 162/97
  • Mainly S.aureus (data for all participants)


InterventionsA: lomefloxacin 200 mg, 3 td
B: norfloxacin 200 mg, 3 td


OutcomesOutcomes of the trial

1) 7 days, cured/improved


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available in the abstract.

Allocation concealment (selection bias)Unclear riskThis was unclear.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "...a double-blind clinical trial." It was unclear who was blinded (and how). The outcome assessor and caregiver were probably not blinded. The participant was probably blinded (see Figure 1 Dosing schedule).

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk33/291 participants were omitted in the analysis: 15/147 in the NY-198 group, 17/144 in the norfloxacin group. There was insufficient information in the abstract and figures.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was no baseline imbalance.

Randomised?Low riskQuote: "...were randomly allocated to one of the two drugs."

Were both inclusion and exclusion criteria specified?Unclear riskInclusion (quote): "...skin and soft tissue infections, patients > 15 years". There was no exclusion criteria.

Arredondo 1987

MethodsTime NR; Mexico city, Mexico; range of skin infections (including impetigo 55/61)


Participants
  • Average age 7 years
  • M/F 30/31
  • S.aureus 67%


InterventionsA: mupirocin ointment 2%, 3 td, 5 to 10 days
B: dicloxacillin 250 mg, 4 td, 5 to 10 days


OutcomesOutcomes of the trial

1) 10 days, cure


NotesOpen trial


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskThis was not mentioned in the article.

Blinding (performance bias and detection bias)
patient
High riskQuote: "In an open trial..." Participants received capsules or ointment. Neither the participant, caregiver, nor outcome assessor were blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk3/61 participants were omitted in the analysis: 2/29 in the mupirocin group, 1/32 in the dicloxacillin group. Reasons for being non-evaluable for clinical outcome were not specified (but this was a small %).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasHigh riskBaseline imbalance: more severe impetigo in the mupirocin group (9/32 vs 3/29, Table 1). There was no data on compliance.

Randomised?Low riskQuote: "After obtaining informed consent, patients were randomly divided into two treatment groups."

Were both inclusion and exclusion criteria specified?Low riskQuote: "...pediatric patients with skin infections of sufficient severity to require treatment with a antibiotic." Quote: "Patients who...were excluded from the trial."

Barton 1987

MethodsJune to August 1986; Missouri, USA; outpatients; only impetigo


Participants
  • Children (age NR)
  • M/F 29/32
  • S.aureus 35/65, Streptococcus 2/65, both: 30%


PE


InterventionsA: penicillin V 50 mg/kg/day in 4 dd, 10 ds
B: erythromycin 40 mg/kg/day in 4 dd, 10 ds


OutcomesOutcomes of the trial

1) 7 days, failure


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available about sequence generation.

Allocation concealment (selection bias)Low riskQuote: "The patients were assigned to receive either erythromycin or penicillin in a random, double-blind fashion by a pharmacist."

Comment: Participants and investigators enrolling participants could not foresee assignment. 

Blinding (performance bias and detection bias)
patient
Unclear riskSee above - it was not specified how this was done. It is unclear whether the caregiver, participant, or outcome assessor was blinded.

Incomplete outcome data (attrition bias)
All outcomes
High risk42/71 participants were omitted in the analysis - reasons and numbers were not specified for each group (6 due to negative culture, 21 not evaluable for effectiveness (not further specified), 6 due to no ascertained compliance, 3 due to no growth of S. aureus alone, 6 withS. aureus alone but not available for follow-up). 14 were left for analysis in the erythromycin group and 15 in the penicillin group.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskCompliance and baseline comparability was unclear.

Randomised?Low riskQuote: "The patients were assigned to receive either erythromycin or penicillin in a random, double-blind fashion by a pharmacist."

Were both inclusion and exclusion criteria specified?Low riskQuote: "All patients examined in the outpatient department between June and August 1986 with primarily non bullous impetigo were asked to participate in the study if they were not receiving antibiotics at the time of being seen at CGH, had not taken antibiotics during the preceding week..."

Barton 1988

MethodsJune to August 1987; Missouri, USA; outpatients; only impetigo


Participants
  • 2 months to 16 years
  • M/F 55/45
  • S. aureus 46/100, S. pyogenes 9/100, both 25/199


PE


InterventionsA: erythromycin 40 mg/kg/day in 4 dd, 10 ds
B: dicloxacillin 25 mg/kg /day in 4 dd, 10 ds


OutcomesOutcomes of the trial

1) 5 to 7 days, cure + improved


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Low riskQuote: "Participants were randomly assigned in a double-blind manner by the hospital pharmacist to receive..." Hence, participants and investigators enrolling participants could not foresee assignment.

Blinding (performance bias and detection bias)
patient
Unclear riskSee above - not specified how and who was blinded.

Incomplete outcome data (attrition bias)
All outcomes
High risk41/100 participants were omitted in analysis - not specified for each group (12/100 were lost to follow up, but not stated from which group). 29 were left in the erythromycin group and 30 left in the dicloxacillin group.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskGroup assignment of non-compliant participants was unclear.

Randomised?Low riskQuote: "Participants were randomly assigned in a double-blind manner by the hospital pharmacist to receive..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "During the months of June, July and August, 1987, 100 children with impetigo, from whom informed consent was obtained, were consecutively enrolled in the study."

Quote: "Exclusion criteria included..."

Barton 1989

MethodsJune to August 1988; Missouri, USA; outpatients; only impetigo


Participants
  • 3 months to 16 years
  • M/F 49/48
  • S. aureus 80%


PNE


InterventionsA: erythromycin 40 mg/kg/day in 3 dd, 7 days
B: mupirocin ointment 2%, 3 td, 7 days


OutcomesOutcomes of the trial

1) 4 to 7 days, cured + improved


Notes14% bullous


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskThis was not mentioned in the article.

Blinding (performance bias and detection bias)
patient
High riskParticipant and caregiver were not blinded because they received either capsules or ointment. It is not mentioned in the article whether the outcome assessor was blinded (probably not, because the caregiver and participant were not blinded)

Incomplete outcome data (attrition bias)
All outcomes
Low risk1(/97) participant was omitted in the analysis, specified: 1/48 in the erythromycin group (lost to follow up), 0/49 in the mupirocin group.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskCompliance was not reported.

Randomised?Low riskQuote: "Participants were randomly assigned to receive either..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Children over 6 weeks of age with a clinical diagnosis of impetigo were invited to participate in the study. Exclusion criteria included..."

Bass 1997

MethodsTime NR; Honolulu, Hawaii; hospital outpatients; only impetigo


Participants
  • Average age 3.8 years
  • Sex NR
  • S. aureus 41/48


PNE


Interventions3 arms:
A: cephalexin 50 mg/kg/day in 3 dd + placebo ointment, 10 days
B: mupirocin ointment 2%, 3 td + liquid oral placebo
C: bacitracin ointment 500 units/g, 3 td + liquid oral placebo


OutcomesOutcomes of the trial

1) 8 to 10 days, cure


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "...clinical pharmacist assigned them by a table of random numbers to one of the three treatment groups".

Allocation concealment (selection bias)Low riskSee above and the quote: "The clinician, patients and their parents were not aware of which of the three treatment regimens they were assigned."

Comment: Central allocation - participants and investigators enrolling participants could not foresee assignment. 

Blinding (performance bias and detection bias)
patient
Low riskQuote: "The clinician, patients and their parents were not aware of which of the three treatment regimens they were assigned."

Comment: The outcome assessor, participant, and caregiver were all blinded.

Incomplete outcome data (attrition bias)
All outcomes
High risk6/32 participants were omitted in the analysis: 0/10 in the cephalexin group, 5/12 in the mupirocin group, 1/10 in the bacitracin group (missing Imbalance for missing data).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was a baseline imbalance for size and type of lesion. Compliance was assessed in only 17 participants.

Randomised?Low riskQuote: "...clinical pharmacist assigned them by a table of random numbers to one of the three treatment groups."

Were both inclusion and exclusion criteria specified?Low riskQuoted from the referred article Demidovich: "Children presenting with impetigo to our clinic were eligible for the study. Exclusion criteria were..."

Beitner 1996

MethodsDecember 1992 to November 1994; 25 centres, Sweden; outpatients; range of skin infections (impetigo 60/327)


Participants
  • Age range 3 to 80 years
  • S. aureus 86% of 327, Streptococcus 14% of 327
  • Included only participants with bacteria sensitive to both drugs


PE


InterventionsA: cefadroxil 40 mg/kg/day, 10 days
B: flucloxacillin tablets 750 mg, 2 td, or susp 30 to 50 mg/kg/day in 2 to 3 dd, 10 days


OutcomesOutcomes of the trial

1) 10 to 12 days, cure/improved/failed


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskThe method of concealment was not described.

Blinding (performance bias and detection bias)
patient
High riskQuote: "...single blinded."

Quote: "Statistical analysis was performed blinded."

Comment: The participant, outcome assessor, and caregiver were probably not blinded because participants in both groups did not receive the same administrations of study drugs daily.

Incomplete outcome data (attrition bias)
All outcomes
High risk334/661 participants were missing mainly due to a lack of a bacterial culture sensitive to both drugs, and 351/661 were omitted from the primary analysis. 33 impetigo participants were included in the primary analysis. Exact reasons for not being evaluable and group assignment were not reported. 19/661 were omitted in the "ITT-analysis".

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskQuote: "The randomization produced two comparable groups of patients with no differences in known prognostic factors." 

Comment: There was no compliance data.

Randomised?Low riskQuote: "In this prospective single-blind comparative and randomized multicentre trial..."

Were both inclusion and exclusion criteria specified?Low riskTable 1: Inclusion and exclusion criteria for the subjects participating in the study.

Blaszcyk 1998

MethodsPeriod NR; multicentre; Europe, Latin America, Asia; range of skin infections (impetigo 42/539)


Participants
  • 16 to 70 years (all participants)


PNE


InterventionsA: clindamycin caps 150 mg, 4 td
B: clindamycin caps 300 mg, 2 td
C: dicloxacillin caps 250 mg, 4 td


OutcomesOutcomes of the trial

1) 7 days, cure


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskQuote: "Drug supplies were masked."

Comment: Insufficient information was available.

Blinding (performance bias and detection bias)
patient
Low riskQuote: "Drug supplies were masked."

Quote: "Patients in all groups received four administrations of study drugs daily."

Comment: The outcome assessor, participant, and caregiver were probably all blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk48/588 were omitted in the analysis: 16/196 in the clindamycin caps 150 mg group, 19/198 in the clindamycin caps 300 mg group, 20/194 in the dicloxacillin caps group. Proportions of participants who did not complete the study medication and reasons were ˜ similar (table II). There were not only impetigo participants.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskCompliance data was provided (table II) and well-balanced. The distribution of baseline characteristics was not provided.

Randomised?Low riskQuote: "This prospective, double mask, randomized study..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Patients were selected based on..."

Quote: "Patients were ineligible if..."

Britton 1990

MethodsOctober 1988 to October 1989; Portsmouth, Virginia, USA; outpatients; only impetigo


Participants
  • 2 months to 12 years
  • M/F 27/17
  • S. aureus 26/48


PNE


InterventionsA: erythromycin 40 mg/kg/day in 4 dd + placebo cream
B: mupirocin ointment 2%, 3 td + placebo susp


OutcomesOutcomes of the trial

1) 10 days, cured + improved


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Using a random numbers table, the hospital pharmacist randomly assigned each patient to one of the groups."

Allocation concealment (selection bias)Low riskQuote: "Using a random numbers table, the hospital pharmacist randomly assigned each patient to one of the groups."

Comment: central allocation - pharmacy-controlled.

Blinding (performance bias and detection bias)
patient
Low riskQuote: "The child group assignment was not known to parents or investigators."

Quote: "...assigned each patient to one of two groups: orally administered erythromycin plus topically applied placebo (erythromycin group) or orally administered placebo plus topically applied mupirocin (mupirocin group)."

Comment: The outcome assessor, participant, and caregiver were probably all blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk6/54 participants were omitted in the analysis: 2/24 in the mupirocin group, 4/30 in the erythromycin group. Participants not completing the study were left out of the analysis. Reasons for not completing the study were not specified for each group. 3 were lost to follow up, 2 dropped out when misdiagnosis was suspected, and 1 was removed because of S. pyogenes pharyngitis. < 20% withdrawals and numbers were balanced.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasHigh riskBaseline characteristics were imbalanced (sex, severity), and compliance was also skewed.

Randomised?Low riskQuote: "Using a random numbers table, the hospital pharmacist randomly assigned each patient to one of the groups."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Children aged 12 years and younger with the clinical diagnosis of impetigo..."

Quote: "We excluded..."

Bucko 2002a

MethodsUnlear, around 2000; US, multicentre; ambulatory setting; range of skin infections (including impetigo 58/857)


Participants
  • 12 to 93 years
  • M/F 427/430
  • S.aureus 525/1685, S.pyogenes 53/1685 (including Bucko 2002b)


PNE


InterventionsA: cefditoren 200 mg, 2 td, 10 days

B: cefditoren 400 mg, 2 td, 10 days

C: cefuroxime 250 mg, 2 td, 10 days


OutcomesOutcomes of the trial

1) 7 to 14 days, cured or improved


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskThis was not reported.

Allocation concealment (selection bias)Low riskQuote: "Study-drug containers were dispensed in numeric sequence at each investigative site as patients were enrolled to ensure random assignment."

Blinding (performance bias and detection bias)
patient
Low riskQuote: "...double-blind, double-dummy..."

Quote: "Patients' evaluability and outcomes were assessed under blinded conditions". The outcome assessor, caregiver, and participant were all blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low riskFor only impetigo: 2/58 missing impetigo participants in total - 0/19 in the cefditoren 200 mg group, 2/21 in the cefditoren 400 mg group, 0/18 in the cefuroxime 250 mg group. Reasons for missing participants were not specified (but a small % were non-evaluable)

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was no compliance data and no baseline imbalance.

Randomised?Low riskQuote: "Patients were randomized."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Eligible patients included..."

Quote: "Study exclusion criteria included..."

Bucko 2002b

MethodsUnclear, around 2000; US; multicentre; ambulatory setting; range of skin infections (including impetigo 74/828)


Participants
  • 12 to 95 years
  • M/F 428/400
  • S.aureus 525/1685, S.pyogenes 53/1685 (including Bucko 2002a)


PNE


InterventionsA: Cefditoren 200 mg, 2 td, 10 days

B: Cefditoren 400 mg, 2 td, 10 days

C: Cefadroxil 500 mg, 2 td, 10 days


OutcomesOutcomes of the trial

1) 7 to 14 days, cured or improved


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskThis was not reported.

Allocation concealment (selection bias)Low riskQuote: "Study-drug containers were dispensed in numeric sequence at each investigative site as patients were enrolled to ensure random assignment."

Blinding (performance bias and detection bias)
patient
Low riskQuote: "...double-blind, double-dummy..."

Quote: "Patients' evaluability and outcomes were assessed under blinded conditions".

Comment: The outcome assessor, caregiver, and participant were all blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low riskFor only impetigo: 4/74 missing participants - 1/27 in the cefditoren 200 mg group, 0/25 in the cefditoren 400 mg group, 3/22 in the cefadroxil 500 mg group. Reasons for missing participants were not specified (but a small % were non-evaluable)

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was no compliance data and no baseline imbalance.

Randomised?Low riskQuote: "Patients were randomized..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Eligible patients included..."

Quote: "Study exclusion criteria included..."

Christensen 1994

MethodsTime NR; Sweden, Germany, UK; Outpatients (Germany) and GP (UK), both (Sweden); only impetigo


Participants
  • 3 + years
  • M/F 131/125
  • S.aureus 199/256, S.pyogenes 21/256, both 36/256


PE


InterventionsA: hydrogen peroxide cream 1% (Microcid), 2 to 3 td, max 21 days
B: fusidic acid cream gel 2%, 2 to 3 td, max 21 days


OutcomesOutcomes of the trial

1) evaluation time NR, cure


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "...randomized (in blocks of four)." The process for selecting the blocks was not specified.

Allocation concealment (selection bias)Unclear riskQuote: "The tubes were put into identical paper boxes, to keep the trials blind."

Comment: Insufficient information was available. The tubes may have been different.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "The tubes were put into identical paper boxes, to keep the trials blind." There was incomplete blinding - participants were probably not blinded (see above), and blinding with regard to the outcome assessor and caregiver is unclear.

Incomplete outcome data (attrition bias)
All outcomes
Low risk135/391 participants were omitted in the analysis because they were culture negative (not specified per group); 11/156 participants in the M-group and 3/156 in the F-group were withdrawn due to deterioration of their impetigo (statistically significant), 3/156 in the F-group and 0/156 in the M-group were withdrawn due to adverse events (irritation of the skin, burning, and blistering). All participants fulfilling the prespecified requirement of bacteriologically-verified impetigo were analysed.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere were no data on baseline comparability and compliance.

Randomised?Low riskQuote: "...randomized (in blocks of four)."

Were both inclusion and exclusion criteria specified?Low riskQuote: "...were included"

Quote: "Patients were not allowed... prior to start of study..."

Ciftci 2002

Methods1999; Turkey; hospital outpatient department; only impetigo


Participants
  • Age 10 to 132 months
  • M/F 32/16
  • S. aureus around 70%


InterventionsA: topical mupirocin 2% 3td for 10 days

B: topical terbinafine 1% 3td for 10 days


OutcomesOutcomes of the trial

1) 10 days, cure


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskInsufficient information was available.

Blinding (performance bias and detection bias)
patient
High riskQuote: "...mupirocin group was instructed to use Bactroban 2% ointment and terbinafine group was instructed to use Lamisil 1% cream topically three times daily for ten days". The outcome assessor, caregiver, and participant were not blinded.

Incomplete outcome data (attrition bias)
All outcomes
High risk14/62 participants were not analysed: 6/31 were missing in the mupirocin group, 8/31 were missing in the terbinafine group. Quote: "At the end of the treatment, 25 participants in the mupirocin group and 23 participants in the terbinafine group were considered eligible" . > 20% missing.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasHigh riskQuote: "The group had similar features except for the time from appearance of lesions to hospital admission." There was a mean of 5.44 in the mupirocin group versus 6.78 in the terbinafine group.

Randomised?Low riskQuote: "...in a randomized fashion."

Were both inclusion and exclusion criteria specified?Low riskQuote: "...were excluded."

Quote: "....children, less than 12 years old, presenting with impetigo to..."

Claudy 2001

MethodsTime NR; France; ambulatory setting (dermatology outpatient departments); range of skin infections (including impetigo 53/334)


Participants
  • All participants: age > 18 years
  • M/F 206/128
  • S aureus: 162/334; S pyogenes 34/334


InterventionsA: oral fusidic acid 2 x 250 mg 2 td for 7.5 days

B: oral pristinamycin 2 x 500 mg 2 td for 10 days


OutcomesOutcomes of the trial

1) 11 days, cured and improved


NotesOutcome data for impetigo participants was provided by the author (personal communication).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskInsufficient information was available.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "Afin de garantir le double insu, chaque patient recevait le traitement dont 2.5 jours de placebo". [To ensure double blinding, each patient received a placebo for 2.5 days]. The participants were blinded, but blinding is unclear with regard to the caregiver and outcome assessor. 

Incomplete outcome data (attrition bias)
All outcomes
Low risk313/334 participants were analysed (< 10% not in analysis). There is no data for impetigo participants.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere were no compliance data and no baseline comparison.

Randomised?Low riskQuote: "Une etude multicentrique, prospective, randomisée..." [A randomised, prospective, multicentre study...]

Were both inclusion and exclusion criteria specified?Low riskQuote: "Tout patient ambulatoire, âgé de plus de 18 ans, avec une pyodermite superficielle nécessitant une antibiothérapie orale et ayant donné son consentement éclairé pouvait être inclus dans l'essai à condition de ne presenter aucun des critères d'exclusion suivants." [Most ambulatory participants, older than the 18 years old, with a superficial pyoderma requiring oral antibiotics and with given informed consent could be included in the study provided there were none of the following exclusion criteria present.]

Dagan 1989

MethodsMay to October 1987; Negev region, Israel; outpatients; only impetigo


Participants
  • 6 months to 9 years
  • Sex NR
  • S. aureus 37/51, S. pyogenes 14/51


PE


InterventionsA: amoxicillin trihydrate syrup 40 mg/kg/day, in 3 dd, 10 days
B: amoxicillin/clavulanic acid syrup 40 + 10 mg/kg/day, in 3 dd, 10 days


OutcomesOutcomes of the trial

1) 5 days, cure + improved


NotesThere was missing data from the first follow-up measurement for 4/26 participants in the amoxicillin trihydrate syrup group and 3/25 participants in the amoxicillin/clavulanic acid syrup group.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskInsufficient information was available.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "...in a double-blind fashion". It is unclear whether the outcome assessor, participant, or caregiver were blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk7/52 (< 20%) participants were omitted in the analysis after 5 days.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasHigh riskThere was a baseline imbalance for lymphadenopathy > 20%. There were no compliance data.

Randomised?Low riskQuote: "After obtaining the cultures, patients were randomized to..."

Were both inclusion and exclusion criteria specified?High riskQuote: "We included..." Exclusion criteria was not mentioned.

Dagan 1992

MethodsJuly 1989 to October 1990; Negev region, Israel; outpatients; only impetigo (bullous and non-bullous)


Participants
  • < 16 years
  • M/F 56/46
  • S. aureus 90/102, streptococci 1/3 of participants


PNE


InterventionsA: erythromycin susp 50 mg/kg/day 3 td + placebo ointment, 7 days
B: mupirocin ointment 2% 3 td + oral placebo susp, 7 days


OutcomesOutcomes of the trial

1) 7 days, failed


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Low riskQuote: "The randomized code was prepared by Beecham Pharmaceutical and was not known to the investigators until after the raw data were tabulated."

Blinding (performance bias and detection bias)
patient
Low riskQuote: "The randomized code was prepared by Beecham Pharmaceutical and was not known to the investigators until after the raw data were tabulated." The erythromycin group received a placebo ointment and the mupirocin group received an oral placebo suspension. The outcome assessor, caregiver, and participant were probably all blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk13/102 participants were omitted in the analysis: 8/51 in the erythromycin group (1 due to side-effects, 7 due to refusal to continue treatment or to return for the follow-up visit), 5/51 missing in the mupirocin group (all due to refusal to continue treatment or to return for the follow-up visit).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere were age and sex differences at baseline (table 1), although they were not significant. There were no compliance data.

Randomised?Low riskQuote: "...were randomized into two groups."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Infants... were enrolled."

Quote: "Excluded groups were..."

Daniel 1991a

Methods1987 to 1991; Belgium, France, FRG, Netherlands, Norway, UK; setting unclear; range of skin infections (including impetigo 69/308)


Participants
  • 16 to 80 years
  • All participants: S. aureus 195/308, streptococci 59/308


PNE


InterventionsA: azithromycin 250 mg twice (day 1),once daily (day 2 to 5), 5 days
B: erythromycin 500 mg 4 td, 7 days


OutcomesOutcomes of the trial

1) 11 to 16 days, cured


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Patients were allocated to treatment with azithromycin or erythromycin in a 1:1 ratio using a randomization list."

Allocation concealment (selection bias)Unclear riskSee above - it is unclear whether participants and investigators enrolling participants could foresee assignment.

Blinding (performance bias and detection bias)
patient
High riskParticipants in both groups did not receive the same administrations of study drugs daily. The outcome assessor was likely to also be the caregiver, so probably all 3 were not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low riskThe number of impetigo participants not included in analysis was small and well-balanced (1 vs 2).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere were no compliance data. Baseline characteristics were well-balanced.

Randomised?Low riskQuote: "Patients were allocated to treatment with azithromycin or erythromycin in a 1:1 ratio using a randomization list."

Were both inclusion and exclusion criteria specified?Low riskQuote: "In order to be included..."

Quote: "Exclusion criteria were..."

Daniel 1991b

Methods1987 to 1989; Belgium, Germany, Ireland, UK; setting unclear; range of skin infections (including impetigo 17/323)


Participants
  • Adults 17 to 90 years
  • All participants: S aureus 158/323, streptococci 41/323


PNE


InterventionsA: azithromycin 250 mg twice (day 1),once daily (day 2 to 5), 5 days
B: cloxacillin 500 mg, 4 td, 7 days


OutcomesOutcomes of the trial

1) 11 to 16 days, cured/improved/failed


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Using a presupplied randomization list patients were allocated to receive azithromycin or cloxacillin in the ratio of 2:1."

Allocation concealment (selection bias)Unclear riskSee above - it is unclear whether participants and investigators enrolling participants could foresee assignment.

Blinding (performance bias and detection bias)
patient
High riskParticipants in both groups did not receive the same administrations of study drugs daily. The outcome assessor, caregiver, and participant were probably not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low riskOnly 1 impetigo participant was not in the analysis.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere were no compliance data. Baseline characteristics were comparable.

Randomised?Low riskQuote: "Using a presupplied randomization list patients were allocated to receive azithromycin or cloxacillin in the ratio of 2:1."

Were both inclusion and exclusion criteria specified?Low riskQuote: "In order to be included..."

Quote: "Exclusion criteria were..."

Demidovich 1990

MethodsTime NR; Honolulu, Hawaii; outpatients; only impetigo


Participants
  • 5 months to 15 years, average 3 years
  • S. aureus 45/73, GABHS 6/73, both 14/73


PNE


InterventionsA: penicillin V 40 to 50 mg/kg/day in 3 dd, 10 days
B: cephalexin 40 to 50 mg/kg/day in 3 dd, 10 days
C: erythromycin 30 to 40 mg/kg/day in 3 dd, 10 days


OutcomesOutcomes of the trial

1) 8 to 10 days, failed


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Low riskQuote: "The pharmacist randomly assigned them to one of three treatment regimens."

Central allocation - participants could not foresee assignment.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "Patients were reevaluated...by one of the authors, both of whom were blinded to the treatment each child was receiving."

Comment: Participants were probably not blinded. The caregiver and outcome assessor were probably blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk2/75 participants were omitted in the analysis: 2 participants were lost to follow up (not further specified).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskQuote: "There was not a significant difference in disease severity among treatment groups." Compliance in both groups was comparable, but low.

Randomised?Low riskQuote: "The pharmacist randomly assigned them to one of three treatment regimens."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Children presenting with impetigo to our pediatric clinic were eligible for the study. Exclusion criteria were..."

Dillon 1983

Methods1980 summer/fall; Alabama, USA; outpatients; only impetigo (bullous impetigo 57/70)


Participants
  • Average age 3.2 years
  • MF 41/37
  • S. aureus: 64/70


PNE


InterventionsA: cephalexin 50 mg/kg/day in 2 dd (> 20 kg: 500 mg 2 td)
B: dicloxacillin 15 mg/kg/day in 4 dd (> 40 kg: 125 mg 4 td)


OutcomesOutcomes of the trial

1) Prompt cure


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Patients were randomly assigned, according to a standard table, to receive..." (Referring to a standard table.)

Allocation concealment (selection bias)Unclear riskSee above - it is unclear whether participants and investigators enrolling participants could foresee assignment.

Blinding (performance bias and detection bias)
patient
High riskParticipants in both groups did not receive the same administrations of study drugs daily. The outcome assessor, caregiver, and participant were probably not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk8/78 participants were omitted in the analysis: 5 vs 3 participants failed to return or, with a negative culture, were not included in the analysis (< 20% and balanced).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskQuote: "Preference was given to patients with skin infections typical of staphylococcal bullous impetigo." Comment: Furthermore, there were no baseline differences, and compliance was not reported.

Randomised?Low riskQuote: "Patients were randomly assigned, according to a standard table, to receive..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "The criterion for enrolment was..."

Quote: "...were excluded."

Dux 1986

MethodsTime NR; Toronto, Canada; setting unclear; range of skin infections (including impetigo 36/149)


Participants
  • Average age 22 years
  • M/F 81/68
  • Bacterial culture results unclear


PNE


InterventionsA: mupirocin ointment 2%, 3 td, 7 days
B: erythromycin 250 mg, 4 td, 7 days
C: cloxacillin 250 mg, 4 td, 7 days


OutcomesOutcomes of the trial

1) 7 days, cure/improved/failure.

Clocacillin: no participants with impetigo allocated


Notes2 cases of secondary impetigo, both in the mupirocin group, were excluded from the results presented here.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information about the sequence generation process was available, and there was unexpected distribution (78 vs 50 vs 20).

Allocation concealment (selection bias)Unclear riskQuote: "...were randomized into two treatment groups by each investigator."

Comment: It is unclear whether participants and investigators enrolling participants could foresee assignment.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "...single-blind".

Comment: It is not clear who was blinded and how this was done. Also, participants in both groups did not receive the same administrations of study drugs daily. Participants were probably not blinded. The blinding of outcome assessor and caregiver is unclear.

Incomplete outcome data (attrition bias)
All outcomes
Low risk1 (/149) participant was omitted in the analysis: 1/79 in the mupirocin group due to an infected cyst (not included in analysis), 0/50 in the erythromycin group, 0/20 in the cloxacillin group.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskCompliance was not reported. There was a large age difference between groups (mean 22 vs 31 years), unknown for impetigo participants.

Randomised?Low riskQuote: "In each section of the study, patients with primary or secondary skin infections were randomized into two treatment groups."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Patients with primary and secondary skin infections that were severe enough were included in three parallel-study groups."

Quote: "Patient who did not..."

Eells 1986

MethodsOctober to November 1983; Puerto Rico; outpatients; only impetigo


Participants
  • 7 months to 13 years
  • M/F 13/25
  • Mainly S.aureus


PE


InterventionsA: mupirocin ointment 2%, 3 td, 7 to 9 days
B: vehicle control, 3 td, 7 to 9 days


OutcomesOutcomes of the trial

1) 8 days, cure/improved/failure

1 participant with ecthyma was excluded in each group.


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Patients were randomized between the two treatment groups by a computer-generated set of random numbers in blocks of five per group."

Allocation concealment (selection bias)Unclear riskInsufficient information was available.

Blinding (performance bias and detection bias)
patient
Low riskQuote: "...double-blind, vehicle-controlled." Also, participants in both groups received the same administrations of study drugs daily. The outcome assessor, caregiver, and participant were probably all blinded.

Incomplete outcome data (attrition bias)
All outcomes
High risk14/52 participants were omitted in the analysis: 8/26 in the mupirocin group (5 were "unavailable for follow-up", 3 for several reasons (specified)), 6/26 in the vehicle group (2 were "unavailable for follow-up", 3 for several reasons (specified)). There were more than 20% withdrawals and dropouts.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was no baseline imbalance. Compliance was not reported.

Randomised?Low riskQuote: "Patients were randomized between the two treatment groups by a computer-generated set of random numbers in blocks of five per group."

Were both inclusion and exclusion criteria specified?Low riskQuote: "...were admitted to the study."

Quote: "Patients were excluded if..."

Esterly 1991

MethodsTime NR; Milwaukee, Wisconsin, USA; outpatients; only impetigo


Participants
  • 3 months to 14 years, average 4.3 years
  • S.aureus 33%; GABHS 12%; both 41%
  • Exclusions: NR


InterventionsA: mupirocin (dose NR)
B: erythromycin (dose NR)


OutcomesOutcomes of the trial

1) Time of evaluation NR, failure


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskIt is unclear whether participants and investigators enrolling participants could foresee assignment.

Blinding (performance bias and detection bias)
patient
High riskOral versus topical treatment. The outcome assessor, caregiver, and participant were probably not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk9/48 participants were omitted in the analysis: 4/25 in the mupirocin group (3 due to "fail to return for follow-up", 1 reason not mentioned), 5/23 in the erythromycin group (3 due to "fail to return for follow-up", 2 reasons not mentioned).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere were no baseline characteristics per group. There were no compliance data.

Randomised?Low riskQuote: "...randomized."

Were both inclusion and exclusion criteria specified?High riskThis was not mentioned in the article.

Farah 1967

MethodsTime NR; Lebanon; outpatients; probably all impetigo ('superificial pyogenic skin infection')


Participants
  • 21 days to 60 years of age
  • M/F unknown
  • S. aureus 61%, S. pyogenes 30%


InterventionsA: gentamycin cream 1% 3 td, duration unknown

B: neomycin ointment 0.5% 3 td, duration unknown


OutcomesOutcomes of the trial

1) Cured, improved after 7 days


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was provided.

Allocation concealment (selection bias)Unclear riskThis was not reported.

Blinding (performance bias and detection bias)
patient
Unclear riskThis was not reported.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk11/139 participants were lost to follow up (it was not stated in which group).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was an unexplained imbalance of group size (88 vs. 44). There were no compliance data. There was no baseline comparison.

Randomised?Low riskQuote: "The persons included in this study were divided into two groups at random."

Were both inclusion and exclusion criteria specified?High riskInclusion and exclusion criteria was not specified.

Faye 2007

Methods2002 to 2003; Mali; hospital outpatients; only impetigo


Participants
  • Inclusion > 1 year of age
  • Mean age 8.5 years
  • M/F 74/58
  • No bacteriological investigation


InterventionsA: oral amoxicillin 50 mg/kg/day + topical 10% povidone iodine for 7 days

B: oral erythromycin 30 mg/kg/day + topical 10% povidone iodine for 7 days


OutcomesOutcomes of the trial

1) Proportion cured + improved after 7 days


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "...using a table of random numbers".

Comment: This was an adequate method.

Allocation concealment (selection bias)Unclear riskInsufficient information was available.

Blinding (performance bias and detection bias)
patient
High riskQuote: "....an open randomized trial."

Quote: "Patients and investigators were not blinded." The outcome assessor, participant, and caregiver were not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk3/132 participants were not analysed: 2/66 in the amoxicillin group (2 lost to follow up on the 7th day), 1/66 in the erythromycin group (1 lost to follow up on the 7th day).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was no baseline comparison. There were no compliance data.

Randomised?Low riskQuote: "...an open randomized trial."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Patients aged more than 1 year old... were considered for inclusion."

Quote: "The following cases were excluded..."

Fujita 1984

MethodsTime NR; Japan; outpatients; range of skin infections (including impetigo 10/204)


Participants
  • Age 16 to 84 years
  • M/F 120/84 (all participants)


InterventionsA: enoxacin 500 mg 3 td
B: cephalexin 500 mg 2 td
(double dummy)


OutcomesOutcomes of the trial

1) After .... cured/improved


NotesSecondary impetigo- it only says impetigo above


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskThis was not mentioned in the abstract.

Allocation concealment (selection bias)Unclear riskThis was not mentioned in the abstract.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "...a double-blind." They used placebo capsules (see Figure 1 Dosage schedule). Participants were probably blinded. It is not clear how, and if, the caregiver and outcome assessor were blinded.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk22/226 participants were omitted in the analysis: 14/115 in the enoxacin group (2 due to exclusion (1 overlap administration and 1 antibiotics before treatment), 12 dropped out (11 shortage of duration, 1 no successive visit)), 8/111 in the cephalexin group (all dropped out (7 shortage of duration, 1 no successive visit). < 20% but not specified for impetigo participants.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was no baseline imbalance (table 4), and compliance was not reported.

Randomised?Unclear riskThis was not mentioned in the abstract.

Were both inclusion and exclusion criteria specified?Unclear riskThis was not mentioned in the abstract.

Gilbert 1989

MethodsTime NR; Quebec, Canada; outpatients; range of skin infections (including impetigo 19/70)


Participants
  • Age NR
  • S. aureus 41/70; Streptococci 22/70 (all participants)


PE


InterventionsA: mupirocin ointment 2%, 3 td, 7 days
B: fusidic acid cream 2%, 3 td, 7 days


OutcomesOutcomes of the trial

1) 7 days, cure/improved/failure


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskInsufficient information was available.

Blinding (performance bias and detection bias)
patient
Unclear riskThe abstract reported the study was double-blind, but it is not explained in the article. There is unclear blinding of the outcome assessor, caregiver, and participant.

Incomplete outcome data (attrition bias)
All outcomes
Low risk1 (/70) participant was omitted in the clinical analysis: 0/35 in the fusidic acid group, 1/35 in the mupirocin group. Participants were not examined if pre-treatment cultures were negative or if post-treatment evaluation was not possible.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was no baseline imbalance, and compliance was not reported.

Randomised?Low riskQuote: "Patients were randomly divided into two treatment groups."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Patients who... were excluded from the trial."

Quote: "...in 70 patients who came to the dermatologic clinic with primary and secondary skin infections of sufficient severity to require antibiotic therapy."

Ginsburg 1978

MethodsTime NR; Dallas, Texas, USA; outpatients; only impetigo


Participants
  • 8 months to 8 years, average 3.1 years
  • Sex NR
  • S.aureus 78%, GABHS 64%, both 50%


Part excluded: unclear


InterventionsA: penicillin G 30 mg/kg/day in 4 dd, duration NR
B: cefadroxil 45 mg/kg/day in 3 dd, duration NR


OutcomesOutcomes of the trial

1) 8 days, cured + improved


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskIt is unclear whether participants and investigators enrolling participants could foresee assignment.

Blinding (performance bias and detection bias)
patient
High riskParticipants in both groups received different administrations of study drugs daily. The outcome assessor, caregiver, and participant were probably not blinded.

Incomplete outcome data (attrition bias)
All outcomes
High risk21/71 participants were omitted in the analysis due to failure to return for both follow-up examinations. There were more than 20% withdrawals; this was not further specified for each group.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskQuote: "Groups were comparable with regard to age, sex, race and extent of skin lesion." Compliance was unclear.

Randomised?Low riskQuote: "Infants and children with impetigo were assigned treatment randomly."

Were both inclusion and exclusion criteria specified?High riskQuote: "Infants and children with impetigo were assigned..." No exclusion criteria were specified.

Giordano 2006

Methods2005; US; hospital outpatients; skin infections (including impetigo 16/391)


Participants
  • All diagnoses: 13 to 93 years
  • M/F 206/185
  • S. aureus 44%; S. pyogenes 2%


InterventionsA: oral cefdinir 300 mg 2 td 10 days

B: cephalexin 200 mg 4 td 10 days


OutcomesOutcomes of the trial

1) Proportion cured + improved after 17 to 24 days


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "A computer-generated randomization schedule in a 1:1 ratio was used."

Quote: "Study drug containers were dispensed in increasing numerical sequence at each investigative site."

Allocation concealment (selection bias)Unclear riskQuote: "To maintain investigator blinding, the study drug was dispensed by an unblinded third person who did not participate in the assessments of clinical response."

Comment: It is not clear whether this person was involved in participant contacts.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "...investigator-blinded."

Quote: "To maintain investigator blinding, the study drug was dispensed by an unblinded third person who did not participate in the assessments of clinical response. Furthermore, the participant was instructed not to disclose any details about the study drug (...) to the investigator." The outcome assessor and caregiver were blinded. The participants were not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low riskThere were 0/16 missing impetigo participants: 0/4 in the cefdinir group, 0/12 in the cephalexin group. All 391 who took at least 1 dose of the study drug were analysed.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere were no compliance data. There was no baseline comparison.

Randomised?Low riskQuote: "A computer-generated randomization schedule..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "...were enrolled"

Quote: "Study exclusion criteria included..."

Goldfarb 1988

MethodsTime NR; Cleveland, Ohio, USA; outpatients; only impetigo


Participants
  • 5 months to 13 years, average 3.8
  • M/F 31/31
  • S.aureus 49/62, Streptococci 4/62, both 9/62


PE: NR


InterventionsA: mupirocin ointment 2%, 3 td, 8 days
B: erythromycin 40 mg/kg/day in 4 dd, 8 days


OutcomesOutcomes of the trial

1) 8 days, cured/failed


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskIt is unclear whether participants and investigators enrolling participants could foresee assignment.

Blinding (performance bias and detection bias)
patient
High riskTopical versus oral treatment. The outcome assessor, caregiver, and participant were probably not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk10/62 participants were lost in total: 5/30 in the mupirocin group (all lost to follow up), 5/32 in the erythromycin group (all lost to follow up).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThe severity of impetigo was not compared between the 2 groups. There was a difference in age (range vs mean). Compliance was not reported.

Randomised?Low riskQuote: "Enrolled children were randomly assigned to groups that..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Children 3 months of age and older were seen at...were eligible for our study."

Quote: "Children were excluded if..."

Gonzalez 1989

MethodsJuly to September 1980; Florida, USA; outpatients; only impetigo (bullous and non-bullous).


Participants
  • 6 months to 12 years


Participants were excluded if no S. aureus was present


InterventionsA: penicillin V potassium 50 mg/kg/day, in 4 dd, 10 days
B: cloxacillin sodium 50 mg/kg/day, in 4 dd, 10 days


OutcomesOutcomes of the trial

1) 10 days: cured + improved


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskQuote: "...on a randomized schedule at the following dosages". It is unclear whether participants and investigators enrolling participants could foresee assignment.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "The clinical examiners were blinded to the antibiotic that the patients received until the study was concluded."

Quote: "...double-blind schedule." It is not clear how patients were blinded, and the participant was likely to be influenced in the case of lack of blinding. The outcome assessor and caregiver were blinded. 

Incomplete outcome data (attrition bias)
All outcomes
High risk24/101 participants were lost due to no S. aureus growth, 10 were lost in failure to return to the clinic (reasons for not attending follow-up visit were not stated). The imbalance in participants was not evaluated.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was no baseline severity comparison between groups. Participant compliance data was computed and presented no significant alterations in therapeutic outcome.

Randomised?Low riskQuote: "...on a randomized schedule at the following dosages..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "...could be enrolled on the study if the following criteria were met..."

Quote: "There were no prior histories of allergic phenomena."

Gould 1984

MethodsTime NR; Edinburgh, UK; general practice; range of skin infections (including impetigo 39/107)


Participants
  • Average age 18.7 (all participants)
  • S. aureus 90/129, streptococci 32/129 (all participants)


PNE


InterventionsA: mupirocin ointment 2%, once daily, until cleared
B: placebo cream, once daily, until cleared


OutcomesOutcomes of the trial

1) Time of evaluation NR, cure/improved/failure


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Patients were allocated a trial number in the consecutive order of their entry in the study. The study was performed under double blind conditions. Medication appropriate to the trial number, either mupirocin or placebo ointment, was dispensed according to a pre-determined randomization which ensured that in each group of four patients, two received treatment with mupirocin and two with placebo ointment." The process for selecting the blocks was not specified.

Allocation concealment (selection bias)Unclear riskInsufficient information was available.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "The study was performed under double-blind conditions." It is unclear whether, and how, the outcome assessor, caregiver, and participant were blinded.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk14/107 participants were omitted in the analysis: 10/54 in the mupirocin group (they were classified as clinically unassessable, 7 did not return for final assessment (5 were traced later and found to have clinically improved), 3 developed other diseases requiring systemic treatment), 4/53 in the placebo group (3 did not return for final assessment (2 of whom were later found to have improved and one worsened and sought alternative treatment), 1 developed other disease requiring systemic treatment). < 20%, 3 vs 1 impetigo participant not evaluable.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskQuote: "...well matched". There was no compliance data.

Randomised?Low riskQuote: "...according to a pre-determined randomization."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Patients with acute primary skin infections...who had not received topical or systemic antibiotics during the preceding 3 days were entered in the study."

Gratton 1987

MethodsTime NR; Montreal, Quebec, Canada; outpatients; range of skin infections (including impetigo 15/60)


Participants
  • Age/sex NR
  • S. aureus approx 50%


PE: NR


InterventionsA: mupirocin ointment 2%, 3 td, 7 days
B: erythromycin 250 mg, 4 td, 7 days


OutcomesOutcomes of the trial

1) 7 days, cure/improved/failure


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskQuote: "...were randomly divided into two treatment groups." It is unclear whether participants and investigators enrolling participants could foresee assignment.

Blinding (performance bias and detection bias)
patient
High riskTopical versus oral treatment. The outcome assessor, caregiver, and participant were probably not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk0/60 participants were omitted in the analysis: 0/30 in the mupirocin group, 0/30 in the erythromycin group. 1 participant in the mupirocin group discontinued therapy due to intolerable side-effects. All impetigo participants were included in the analysis.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was no baseline data. There were no compliance data.

Randomised?Low riskQuote: "...were randomly divided into two treatment groups."

Were both inclusion and exclusion criteria specified?High riskQuote: "Sixty patients with primary and secondary skin infections were randomly divided." No exclusion criteria was specified.

Hains 1989

MethodsSummer 1986; Birmingham, Alabama, US; outpatients child hospital; only impetigo


Participants
  • 1 to 18 years
  • Sex NR
  • S. aureus 35%, GABHS 12%, both 54%


PE: NR


InterventionsA: cefadroxil 30 mg/kg/day, max 1 g, in 1 dd, 10 days
B: cephalexin 30 mg/kg/day, max 1 g, in 2 dd, 10 days


OutcomesOutcomes of the trial

1) 14 days, cured


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskQuote: "Patients were randomly assigned to receive either..." It is unclear whether participants and investigators enrolling patients could foresee assignment.

Blinding (performance bias and detection bias)
patient
High riskParticipants in both groups received different administrations of study drugs daily. The outcome assessor, caregiver, and participant were probably not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk13/101 participants were omitted in the analysis in total: 4/55 in the cefadroxil group (1 failed to keep all of the appointments, 3 participants failed to take medications as prescribed), 9/54 in the cephalexin group (3 with negative cultures, 4 failed to keep all of the appointments, 2 participants failed to take medications as prescribed). < 20% and reasons described.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was baseline data. Compliance was good in both groups.

Randomised?Low riskQuote: "Patients were randomly assigned to receive either..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "...who had a clinical diagnosis of pyoderma were enrolled."

Quote: "Children were excluded if..."

Ishii 1977

MethodsSummer 1976; Tokyo, Japan; hospital outpatient clinic; bullous impetigo


Participants
  • 0 to 10 years
  • M/F 26/34
  • No bacterial investigations
  • All participants evaluable


InterventionsA: topical Eksalbe simplex (ointment containing killed escherichia, staphylococcus, streptococcus, and pseudomonas) applied once daily under plaster or 3 times daily without plaster

B: placebo


OutcomesOutcomes of the trial

1) Cured/improved after 4 days


NotesData extraction and risk of bias assessment done by Testuri Matsumura.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskThis was not reported.

Allocation concealment (selection bias)Low riskAllocation was concealed (assessed by Tetsuru Matsumura).

Blinding (performance bias and detection bias)
patient
Low riskThe participant, outcome assessor, and caregiver were blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk2/40 participants were dropouts and excluded from the analysis.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere were no compliance data.

Randomised?Low riskThis trial was randomised (assessed by Tetsuru Matsumura).

Were both inclusion and exclusion criteria specified?High riskExclusion criteria were not specified.

Jaffe 1985

MethodsTime NR; Cleveland, Ohio, USA; outpatients child clinic; range of skin infections (including impetigo 32/42)


Participants
  • 6 months to 12 years, average 4.8 years
  • S. aureus 33/36, S. pyogenes 8/36


PNE


InterventionsA: amoxicillin/clavulanic (125/30) acid, dose equivalent to 20 mg amoxicillin/kg/day in 3 dd, 10 days
B: cefaclor 20 mg/kg/day in 3 dd


OutcomesOutcomes of the trial

1) 10 days, cured/failed


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Low riskQuote: "Prescription were filled by the hospital pharmacist using double-blind labels." Personnel or participants could, probably, not foresee assignment.

Blinding (performance bias and detection bias)
patient
Low riskQuote: "Prescription were filled by the hospital pharmacist using double-blind labels." The outcome assessor, caregiver, and participant were probably all blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk0/43 participants were omitted in the analysis: 0/21 in the amoxicillin/clavulanic acid group, 0/22 in the cefaclor group.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasLow riskQuote: "The two treatment groups were generally comparable." Compliance was good in 75% of participants.

Randomised?Low riskQuote: "Children were randomly assigned to one of the two treatment regimens."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Children 6 months to...were eligible for inclusion in the study."

Quote: "Exclusion criteria included..."

Jaffe 1986

MethodsTime NR; multicentre, Wessex, UK; general practice; range of skin infections (including impetigo 43/119)


Participants
  • 2.5 years to 83 years, median 14 to 16 years
  • M/F 23/20
  • S. aureus 16/34, S. pyogenes 5/34


PNE


InterventionsA: 1% hydrocortisone + 0.5% potassium hydroxyquinoline sulphate cream, 2 td, 14 days
B: 1% hydrocortisone + 2% miconazole nitrate cream, 2 td, 14 days


OutcomesOutcomes of the trial

7 days, cured/improved


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskQuote: "The trial was double-blind, patients being allocated at random to receive..."

Quote: "The randomization was balanced for each centre, with separate randomizations for each of the two indications." It is unclear whether participants and investigators enrolling participants could foresee assignment.

Blinding (performance bias and detection bias)
patient
Low riskQuote: "Unmarked plain tubes of the marketed formulation of each product were packed in plain sealed cartons, neither doctors nor patients being aware of the identity of the products until the end of the study."

Comment: The outcome assessor, caregiver, and participant were probably blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk0/119 participants were omitted in the analysis: 0/65 in group 1, 0/54 in group 2.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskDetails of age, duration of condition, and total symptom severity score were recorded and were similar. There were no compliance data.

Randomised?Low riskQuote: "The trial was double-blind, patients being allocated at random to receive..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "...who presented... were included in the study." Exclusion criteria was not specified.

Kennedy 1985

MethodsTime NR; Bristol, UK; general practice; only impetigo


Participants
  • Average age 11 years (mupirocin), 17 years (neomycin)
  • M/F 2/1
  • S. aureus 23/34, S. pyogenes 10/34


PNE


InterventionsA: mupirocin ointment 2%, 2 td, 10 to 11 days
B: neomycin ointment 1%, 2 td, 10 to 11 days


OutcomesOutcomes of the trial

1) Time of evaluation NR, cure/improved/failure


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Allocation of treatment was on a randomized basis. In each consecutive group of four patients, two received Bactroban ointment and two received neomycin."

Comment: They probably used blocked randomisation, but the process of selecting the blocks was not specified.

Allocation concealment (selection bias)Unclear riskIt is unclear whether participants and investigators enrolling participants could foresee assignment.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "The 15-g tubes differed only in their code numbers and in both cases the content was a white ointment." It is unclear how investigators were blinded. The caregiver and participant were probably blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk9/41 participants were omitted in the analysis: 8 were excluded due to a "stated diagnosis other than uncomplicated impetigo" (not stated which group), 1 missing from the mupirocin group due to "failure to attend to follow-up".

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was baseline imbalance for age (mean 11 vs 17 years). There were no compliance data.

Randomised?Low riskQuote: "Allocation of treatment was on a randomized basis."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Patients were selected from those presenting with typical impetigo."

Quote: "Patients were excluded if..."

Kiani 1991

MethodsTime NR; multicentre USA (Southern States); admitted + outpatients; range of skin infections (including impetigo 18/179)


Participants
  • Age > 16, 211/154 (all participants)
  • S. aureus 152/179, S. pyogenes 29/179 (all participants)


PE


InterventionsA: azithromycin 500 mg day 1, 250 mg, day 2 to 5, 5 days
B: cephalexin 500 mg twice daily, 10 days


OutcomesOutcomes of the trial

1) 11 days, cured/improved


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskInsufficient information was available.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "In this double blind..."

Quote: "Using a double-dummy technique, each patient received placebo capsules which were visually identical to the active drugs."

Comment: The caregiver and participant were probably blinded. There was unclear blinding of the outcome assessor.

Incomplete outcome data (attrition bias)
All outcomes
High risk187/366 participants were omitted in the analysis: 99/182 in the azithromycin group (58 due to "no baseline pathogen", 15 due to "no end of therapy assessment", 15 due to "the presence of a resistant pathogen" (only main reasons mentioned)), 88/184 in the cephalexin group (55 due to "no baseline pathogen", 6 due to "no end of therapy assessment", 6 due to "the presence of a resistant pathogen" (main reasons mentioned)). > 20% no end of therapy assessment (not specified for impetigo only).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was a baseline comparison for sex, race, and primary diagnosis. There was no baseline imbalance. There were no compliance data.

Randomised?Low riskQuote: "Patients were randomly assigned in a double-blind fashion to one of the two treatment groups."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Patients were entered in the study based on..."

Quote: "...were excluded by the protocol."

Koning 2003

MethodsFebruary 1999 to November 2000; Rotterdam, Netherlands; general practice; only impetigo


Participants
  • < 12, average age 5.0 years
  • M/F 98/62
  • S. aureus 127/160, S. pyogenes 5/160, both 8/160, none 20/160


PNE


InterventionsA: fusidic acid cream 2%, 3 td + povidone iodine shampoo, 2 td
B: placebo cream, 3 td + povidone iodine shampoo, 2 td


OutcomesOutcomes of the trial

1) 7 days, cure


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "An independent statistician provided a computer-generated list of random set numbers in permuted blocks of six. The hospital pharmacist packed the study medication in identical blank tubes with a number according to the randomisation list."

Allocation concealment (selection bias)Low riskSee above - probably done: central allocation.

Blinding (performance bias and detection bias)
patient
Low riskQuote: "Unblinding took place after the primary statistical analysis had been done."

Quote: "....research nurse was unaware of treatment allocation."

Quote: "...placebo cream did not differ."

Quote: "Unblinding took place after the primary statistical analysis had been done."

Comment: The outcome assessor, caregiver, and participant were probably all blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk4/160 participants were omitted in the analysis (after 1 week): 2/78 in the fusidic acid cream group (both did not want to follow up), 2/82 in the placebo cream group (both did not want to follow up).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was no baseline imbalance. There was more non-compliance in the placebo group.

Randomised?Low riskQuote: "Patients were randomised blockwise."

Were both inclusion and exclusion criteria specified?Low riskQuote: "General practitioners (GP's) in the Greater Rotterdam were asked to report patients aged 0-12 years with nonbullous impetigo presenting at their surgery."

Quote: "Exclusion criteria were..."

Koning 2008

MethodsApril to December 2005; India, Mexico, Netherlands, Peru; hospital outpatients and general practice patients; only impetigo


Participants
  • 0 to 73 years of age, mean age around 11 years
  • M/F 107/103
  • S. aureus 146/210, S. pyogenes 42/210


InterventionsA: topical retapamulin 1% 2 td for 5 days

B: topical placebo 2 td for 5 days


OutcomesOutcomes of the trial

1) Cured or improved after 7 days


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Low riskQuote: "Randomization was centre based and performed using an automated telephone system."

Blinding (performance bias and detection bias)
patient
Low riskQuote: "The packaging and labelling of study medication was identical for the active medication and its placebo counterpart. All efforts were made to make the study medication and placebo identical with respect to appearance and smell." The outcome assessor, caregiver, and participant were all blinded.

Incomplete outcome data (attrition bias)
All outcomes
High risk50/213 participants missing in total: 18/140 in the retapamulin group (1 did not receive intervention, 17 withdrawals (5 lack of efficacy, 3 disease progression, 2 decided to withdraw, 1 adverse event, 5 lost to follow up)), 33/73 in the placebo group (2 did not receive intervention, 31 withdrawals (18 lack of efficacy, 9 disease progression, 1 adverse event, 3 lost to follow up)). > 20% missing data.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskQuote: "The mean total lesion area at baseline was larger in the retapamulin group compared with the placebo group." There was an imbalance for age. There were no compliance data.

Randomised?Low riskQuote: "We carried out a randomized..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Inclusion criteria were..."

Quote: "...were excluded."

Koranyi 1976

Methods1974; Columbus, Ohio, USA; outpatients; only impetigo


Participants
  • 2 months to 15 years
  • M/F 14/16
  • S. aureus 22/30, S. pyogenes 10/30


PNE


InterventionsA: bacitracin ointment 500 units/g, 4 td + oral placebo 6 days
B: erythromycin 250 mg 4 td + placebo cream, 6 days


OutcomesOutcomes of the trial

1) 6 days, cured/improved


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Drug assignment was based on a random distribution table, without the knowledge of the authors."

Allocation concealment (selection bias)Low riskSee above.

Blinding (performance bias and detection bias)
patient
Low riskSee above. Also double dummy design. The outcome assessor, caregiver, and participant were all blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk0/30 participants were omitted in the analysis: 0/15 in the bacitracin group, 0/15 in the erythromycin group.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was no baseline comparison for the most important prognostic factors. There were no compliance data.

Randomised?Low riskQuote: "Drug assignment was based on a random distribution table, without the knowledge of the authors."

Were both inclusion and exclusion criteria specified?Low riskQuote: "...were enrolled in the study."

Quote: "...were excluded."

Kuniyuki 2005

Methods2002 to 2003; Japan; hospital outpatients; only impetigo


Participants
  • 2 months to 13 years
  • M/F 27/22
  • S. aureus 49/49 (inclusion criterion)


InterventionsA: topical tetracycline 3% 3 td + oral cefdinir 9 mg/kg/day for 7 days
B: topical tetracycline 3% 3 td + oral minomycin 4 mg/kg/day for 7 days
C: topical tetracycline 3% 3 td + oral fosfomycin 40 mg/kg/day for 7 days
D: topical tetracycline 3% 3 td for 7 days


OutcomesOutcomes of the trial

1) Cured, improved after 7 days


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskThis was not reported.

Allocation concealment (selection bias)Unclear riskThis was not reported.

Blinding (performance bias and detection bias)
patient
High riskQuote: "...open-label." The outcome assessor, caregiver, and participant were not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskOnly participants who were culture positive were analysed. The number of dropouts and withdrawals was not mentioned.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere were no compliance data. There was a baseline comparison for age and sex - no imbalance.

Randomised?Low riskQuote: "...randomized".

Were both inclusion and exclusion criteria specified?Low riskQuote: "...were admitted to the study."

Quote: "We excluded patients..."

McLinn 1988

MethodsFebruary to May 1986 ; Scottsdale, Arizona, USA; outpatients; only impetigo


Participants
  • > 6 months, average 5.5 years
  • S.aureus 43/60, S.pyogenes 17/60


PE


InterventionsA: mupirocin ointment 2%, 3 td, 7 to 9 days
B: erythromycin 30 to 40/mg/kg/day in 3 to 4 doses, 7 to 9 days


OutcomesOutcomes of the trial

1) 8 to 12 days, very much improved/ improved/no change


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Patients were randomized between the two treatment groups by a computer-generated set of random numbers in blocks of four."

Allocation concealment (selection bias)Low riskQuote: "...investigator was blinded to the treatment the patient was to receive at the time of patient entry."

Blinding (performance bias and detection bias)
patient
High riskQuote: "The investigator was blinded to the treatment the patient was to receive at the time of patient entry and was unblinded only in those cases where lesions persisted requiring additional culturing." Quote: "...open-label". This was not blinded for all participants. Also topical versus oral treatment. The outcome assessor and caregiver were not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk0/60 participants were omitted in the analysis for clinical efficacy: 0/30 in the mupirocin group, 0/30 in the erythromycin group (2 participants in the erythromycin group discontinued therapy because of severe adverse experiences).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was a severe baseline imbalance, more fever in erythromycin group (12 versus 3), but they seem to have adjusted for this in the analysis. There were no compliance data.

Randomised?Low riskQuote: "Patients were randomized between the two treatment groups by a computer-generated set of random numbers in blocks of four."

Were both inclusion and exclusion criteria specified?Low riskQuote: "...were enrolled in the study."

Quote: "Patients with...were excluded."

Mertz 1989

MethodsTime NR; San Juan, Puerto Rico; outpatients; only impetigo


Participants
  • 6 months to 32 years, average 5.4 years
  • M/F 27/26; S.aureus 44/53, GABHS 37/53


PE


InterventionsA: mupirocin ointment 2%, 3 td, 7 to 9 days
C: erythromycin 30 to 50 mg/kg/day in 2 doses, 7 to 9 days


OutcomesOutcomes of the trial

1) 7 to 9 days, cured/improved


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Patients were randomized between the two treatment groups according to a computer-generated schedule having a block size of four."

Allocation concealment (selection bias)Low riskSee above, and Quote: "The randomization was predetermined by the sponsor and the schedule for distribution of medications was entrusted to a team member whose assignment was to dispense medication."

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "...were examined in a investigator-blinded study."

Quote: "The randomization was predetermined by the sponsor and the schedule for distribution of medications was entrusted to a team member whose assignment was to dispense medication." Also, there was treatment with ointment versus capsules. The outcome assessor was blinded. The caregiver and the participant were not blinded.

Incomplete outcome data (attrition bias)
All outcomes
High risk22/75 participants were omitted in the analysis: 9 were missing in the mupirocin group (unclear why), 13 were missing in the in the erythromycin group (unclear why).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was an imbalance for sex: 17/28 versus 10/25 boys (assessable participants) = 61% vs 40%. There was no compliance data.

Randomised?Low riskQuote: "Patients were randomized between the two treatment groups according to a computer-generated schedule having a block size of four."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Patients 3 months of age and older of either sex who had no more than seven lesions of impetigo, cellulitis, abscesses, or furunculosis were admitted to the study."

Montero 1996

MethodsTime NR; multicentre; Columbia Guatemala, Panama, South Africa; outpatients; range of skin infections (including impetigo 95/200)


Participants
  • 6 months to 12 years
  • M/F 101/94 (all participants)
  • S.aureus 109/200, S.pyogenes 39/200


PNE


InterventionsA: azithromycin susp 10 mg/kg/day once daily, 3 days
B: cefaclor susp 20 mg/kg/day in 3 doses, 10 days


OutcomesOutcomes of the trial

1) 10 to 14 days, cured + improved


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskQuote: "Patients were randomly assigned in a 1:1 ratio to receive either..." It is unclear whether participants and investigators enrolling participants could foresee assignment.

Blinding (performance bias and detection bias)
patient
High riskQuote: "This open, comparative study..." Participants in both groups did not receive the same administrations of study drugs daily.

Comment: The outcome assessor, caregiver, and participant were probably not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk4/100 participants were omitted in the analysis (all attritions): 2/100 in the azithromycin group (due to loss of follow up), 2/100 in the cefaclor group (due to loss of follow up).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was no baseline imbalance for gender, age, weight, height, and ethnic origin. There were no compliance data.

Randomised?Low riskQuote: "Patients were randomly assigned in a 1:1 ratio to receive either..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Two hundred children...entered this multicentre..."

Quote: "Patients were excluded from the study if...shown in Table I."

Moraes Barbosa 1986

MethodsTime NR; Rio de Janeiro, Brasil; hospital outpatients; only impetigo


Participants
  • Newborns, age 3 to 14 days, average 11 days
  • M/F 25/23
  • S.aureus 100% (required for inclusion)


Interventions4 arms:
A: sodium fusidate ointment 2%, 3 td, 10 days
B: chloramphenicol ointment, 3 td, 10 days
C: neomycin/bacitracin ointment, 3 td, 10 days
D: erythromycin oral 50 mg/kg/day, in 4 dd, 10 days


OutcomesOutcomes of the trial

1) 7 days, cure


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskInsufficient information was available.

Blinding (performance bias and detection bias)
patient
High riskOral versus topical treatment. The outcome assessor, caregiver, and participant were probably not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll 48 participants were analysed (see table 2).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere were no differences for sex. No other characteristics were reported. There were no compliance data.

Randomised?Low riskQuote: "Estes foram divididos aleatoriamente em quatro grupos de 12." [They were randomly divided in 4 groups of 12.]

Were both inclusion and exclusion criteria specified?High riskQuote: "Quarenta e oito recem-nascidos entre tres e 14 dias de idade, portadores de impetigo estafilococico sem tratamento topica ou oral anterior, foram incluidos neste estudo." [40 and 8 neonates between 3 and 14 days old, who were carriers of impetigo stafylococcus without previous topical or oral treatment, had been enclosed in this study.] No exclusion criteria was specified.

Morley 1988

MethodsTime NR; Plymouth/Bristol, UK; general practice; range of skin infections (including impetigo 89/354)


Participants
  • 1 to 92 years, average 33 years (all participants)
  • M/F 162/192 (all participants)
  • S.aureus 119/344, S.pyogenes 15/344, both 25/344 (all participants)


PNE


InterventionsA: fusidic acid ointment 2%, 3 td, up to 7 days
B: mupirocin ointment 2%, 3 td, up to 7 days


OutcomesOutcomes of the trial

1) 6 to 8 days, excellent/good


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Low riskQuote: "On entry, patients were allocated at random to receive one or other treatment, tubes of the ointment being provided in plain sealed numbered containers so that the investigator was unaware of the treatment given."

Comment: This was probably done.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "On entry, patients were allocated at random to receive one or the other treatment, tubes of the ointment being provided in plain sealed numbered containers so that the investigator was unaware of the treatment given."

Comment: The participants were probably blinded because the tubes were plain sealed. The outcome assessor was blinded. It is unclear whether the caregiver was blinded (it is unclear if the outcome assessor was also the caregiver).

Incomplete outcome data (attrition bias)
All outcomes
Low risk0/354 participants were omitted in the analysis: 0/191 in the sodium fusidate group, 0/163 in the mupirocin group. Therapy was withdrawn in only 2 cases - 1 in each treatment group.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was baseline comparison for sex, age, and severity. There were no compliance data.

Randomised?Low riskQuote: "On entry, patients were allocated at random to receive one or other treatment."

Were both inclusion and exclusion criteria specified?Low riskQuote: "The study involved 354 patients with acute superficial skin sepsis amenable to therapy with a topical antibiotic."

Quote: "Patients who...were excluded."  

Quote: "...were also exclusion factors."

Nolting 1988

MethodsTime NR; Münster, Germany; outpatients; range of skin infections (including impetigo 66/80)


Participants
  • 1 to 65 years, average 24 years
  • M/F 35/31
  • S.aureus 41/66, GABHS 8/66, both 17/66


PE


InterventionsA: sulconazole nitrate cream 1%, 2 td, 14 days
B: miconazole nitrate cream 2%, 2 td, 14 days


OutcomesOutcomes of the trial

1) 7 days/14 days, cure


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "When patients enrolled in the trial, they were allocated, according to a computer-generated randomization code, to receive either..."

Allocation concealment (selection bias)Unclear riskInsufficient information was available.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "...double-blind, parallel comparative study". It is unclear if, and how, the outcome assessor, caregiver, and participant were blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk0/80 participants were omitted in the analysis: 0/40 in the sulconazole group, 0/40 in the miconazole group.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThe proportion of micro-organisms isolated at admission differs between groups (19 vs 6 for streptococcus, 53 vs 71 for S. aureus). There were no compliance data.

Randomised?Low riskQuote: "...according to a computer-generated randomization code..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Patients...were admitted to the trial."

Quote: "...were excluded from the trial."

Oranje 2007

Methods2005; Canada, Costa Rica, France, Germany, India, The Netherlands, Peru, Poland, South Africa; outpatients; only impetigo


Participants
  • 9 months to 84 years
  • M/F 278/239
  • S. aureus 341/517, S. pyogenes 137/517


InterventionsA: topical retapamulin 1% 2 td for 5 days
B: topical sodium fusidate 2% 3 td for 7 days


OutcomesOutcomes of the trial

1) Cure or improvement after 7 (retapamulin) or 9 days (sodium fusidate)


NotesRandomisation was 2:1.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskThis was not reported.

Allocation concealment (selection bias)Low riskQuote: "...predetermined, center-based 2:1 schedule using the telephone-based interactive, central Registration and Medication Ordering System."

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "...observer-blinded..."

Quote: "...helped protect investigator blinding."

Quote: "To maintain observer blinding..." Participants in both groups did not receive the same administrations of study drugs daily. Participants were not blinded, the outcome assessor was blinded, and the blinding of the caregiver is unclear

Incomplete outcome data (attrition bias)
All outcomes
Low risk41/519 participants were missing data in both groups: 26/346 in the retapamulin group (26 prematurely discontinued, of which 8 had disease progression, 8 were lost to follow up, 1 had adverse events, 1 through lack of efficacy, 1 through protocol violation, 1 through potential conflicts of interest, 3 through 'other'), 15/172 in the sodium fusidate group (15 prematurely discontinued, of which 6 had disease progression, 1 was lost to follow up, 1 through subject decision [participant decision?], 3 had adverse events, 1 through lack of efficacy, 3 through 'other'), 1/519 were not included in the analysis.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was no baseline imbalance. Compliance was comparable.

Randomised?Low riskQuote: "This was a randomised..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Subjects were included if..."

Quote: "Subjects were excluded if..."

Pruksachat 1993

MethodsDecember 1988 to November 1990; Chiang Mai, Thailand; outpatients; only impetigo


Participants
  • 1 months to 8 years, median 3.5 years
  • M/F 64/46 (all participants)
  • S. aureus 77/110


PE


InterventionsA: penicillin V potassium 50 mg/kg/day in 4 doses, 7 days
B: cloxacillin sodium 50 mg/kg/day in 4 doses, 7 days


OutcomesOutcomes of the trial

1) 7 days, cure


NotesBullous and non-bullous impetigo.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskIt is unclear whether participants and investigators enrolling participants could foresee assignment.

Blinding (performance bias and detection bias)
patient
High riskThis was not mentioned in the article: If the outcome assessor, caregiver, or participant was not blinded, he or she is likely to cause bias. All 3 were probably not blinded.

Incomplete outcome data (attrition bias)
All outcomes
High risk20/110 participants were omitted in the analysis: 45 were treated in the penicillin group and 45 were in the cloxacillin group (9 were unavailable for follow-up and 11 were negative to culture - not specified per group).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere were no baseline characteristics per group. There were no compliance data.

Randomised?Low riskQuote: "Participants were randomly assigned to receive either..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Children... were invited to participate in the study."

Quote: "Inclusion criteria included..."

Rice 1992

MethodsApril to November 1989; Baltimore, USA; outpatients and general practice; only impetigo


Participants
  • 3 months to 16 years
  • MF 53/30
  • Culture only in case of therapy failure


PNE


InterventionsA: erythromycin ethynyl succinate 40 mg/kg/day in 4 doses, 10 days
B: mupirocin ointment 2%, 3 td, 10 days


OutcomesOutcomes of the trial

1) 9 to 11 days, cure/improved/failure


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskIt is unclear whether participants and investigators enrolling participants could foresee assignment.

Blinding (performance bias and detection bias)
patient
High riskQuote: "In any clinical trial that is not blinded..." Also, oral versus topical treatment. The outcome assessor, caregiver, and participant were not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk10/93 participants were omitted in the analysis. The following were specified: 4/46 in the erythromycin group (4 did not return for follow-up), 6/47 in the mupirocin group (4 did not return for follow-up, 2 were excluded from completing the protocol, 1 had cellulites develop within a few hours after entry into the study, 1 whose primary provider added an oral antibiotic to the treatment regimen on day 3 of therapy even though the participant's condition was improving).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasLow riskThe baseline characteristics were comparable. Compliance was good and comparable (table 6).

Randomised?Low riskQuote: "Children were randomly assigned to the two study groups."

Were both inclusion and exclusion criteria specified?Low riskQuote: "All children... were invited to participate."

Quote: "Exclusion criteria included..."

Rist 2002

MethodsTime NR; USA; outpatients; secondary impetigo (all eczema)


Participants
  • 9 to 87 years
  • M/F 87/72
  • S. aureus 74/159, S. pyogenes 0/159


InterventionsA: topical mupirocin 2% 3 td + oral placebo for 10 days
B: oral cephalexin 250 mg 4 td + topical placebo for 10 days


OutcomesOutcomes of the trial

1) Cured or improved after 12 to 13 days


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskInsufficient information was available.

Blinding (performance bias and detection bias)
patient
Low riskQuote: "...double-blind, double-dummy, parallel-group trial..." The outcome assessor, caregiver, and participant were all blinded.

Incomplete outcome data (attrition bias)
All outcomes
High risk33/159 (> 20%) participants did not complete the study (not specified per group). All 159 were in the ITT analysis. Participants whose outcome was indeterminable were considered failures. This may have introduced bias.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskQuote: "Compliance was similar for both groups."

Quote: "The mean SIRS scores were 20.5 for the mupirocin group and 19,1 for the cephalexin group (P = 0.09)." There was an imbalance for sex.

Randomised?Low riskQuote: "In this randomized..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Patients were eligible for entry into the trial if..."

Quote: "Patients were excluded from the study if..."

Rodriguez-Solares 1993

MethodsTime NR; multicentre; Costa Rica, Guatemala, Panama, Venezuela; outpatients; range of skin infections (including impetigo 39/118)


Participants
  • 2 to 12 years, mean 5 years
  • M/F NR
  • S. aureus 69/118, S. pyogenes 9/118 (all participants)


PNE


Interventions3 arms:
A: azithromycin 10 mg/kg/day (max. 500), once daily, 3 days
B: dicloxacillin12.5 to 25 mg/kg/day in 4 doses, 7 days (see notes)
C: flucloxacillin 500 to 2000 mg/day in 4 doses (see notes)


OutcomesOutcomes of the trial

1) 7 to 10 days, cure/improved/failure


NotesRandomisation was between azithromycin and, either, dicloxacillin or flucloxacillin; the treatment groups dicloxacillin and flucloxacillin are combined in the results


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was provided.

Allocation concealment (selection bias)Unclear riskInsufficient information was provided.

Blinding (performance bias and detection bias)
patient
High riskQuote: "An open, randomized..." The outcome assessor, caregiver, and participant were not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low riskOnly 1 participant was missing (in which group was not specified).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was no baseline comparison (or compliance data) for the subgroup of impetigo participants.

Randomised?Low riskQuote: "An open, randomized..."

Quote: "60 were randomized to receive..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Children...were eligible to enter this study."

Quote: "Concurrent treatment with...was not permitted."

Quote: "The principal exclusion criteria were..."

Quote: "Persons were also excluded if..."

Rojas 1985

MethodsTime NR; Dominican Republic; hospital outpatients; only impetigo


Participants
  • Age and M/F ratio NR
  • Bacterial results NR


PE


InterventionsA: mupirocin ointment 2%, 3 td, 10 to 12 days
B: placebo/vehicle, 3 td, 10 to 12 days


OutcomesOutcomes of the trial

1) 7 to 12 days, cure/improved


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskInsufficient information was available.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "The medication was numerically labelled; the protocol ensured double-blind comparisons." Bactroban ointment versus vehicle ointment. It is not clear whether the caregiver and outcome assessor are the same person. There was unclear blinding of the outcome assessor. The participant and the caregiver were probably blinded.

Incomplete outcome data (attrition bias)
All outcomes
High riskQuote: "Fifty patients completed the study." The number of participants that entered into the study was not specified.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was no baseline data. There were no compliance data.

Randomised?Low riskBactroban ointment versus vehicle ointment - so, probably randomised but not clearly described.

Were both inclusion and exclusion criteria specified?High riskQuote: "Patients with...entered in the study sequentially." No exclusion criteria was specified.

Ruby 1973

MethodsSummer 1972; Dallas, USA; outpatients; only impetigo


Participants
  • Children, age NR
  • M/F 43/59
  • Only GABHS 33/102, both S. aureus and GABHS 57/102


PNE


Interventions5 arms:
A: phenoxymethyl penicillin 40 to 60,000 units/kg/day in 3 doses + HS
B: phenoxymethyl penicillin 40 to 60,000 units/kg/day in 3 doses
C: HS + placebo
D: placebo, 3 td
E: bacitracin ointment, 2 td


OutcomesOutcomes of the trial

1) 5 days, cure


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Patients were assigned to one of five treatment groups by a random numbers list."

Quote: "When more than one child from an household was entered in the study, all those children received the same treatment."

Comment: This was probably done.

Allocation concealment (selection bias)High riskQuote: "Patients were assigned to one of five treatment groups by a random numbers list."

Quote: "When more than one child from an household was entered in the study, all those children received the same treatment." Investigators knew that children in the same household got the same treatment.

Blinding (performance bias and detection bias)
patient
High riskQuote: "Phenoxymethyl penicillin suspension and placebo were coded as 'impecillin' and 'tigocillin'". Also, ointment versus suspension. The bacitracin was not placebo-controlled.

Comment: The outcome assessor, caregiver, and participant were probably not blinded.

Incomplete outcome data (attrition bias)
All outcomes
High risk24/102 participants were omitted in the analysis: 0/20 in group A (penicillin + hexachlorophene), 2/20 in group B (penicillin) (2 not streptococcal positive), 12/23 in group C (placebo) (6 not streptococcal positive, 6 failed to return for first follow-up), 4/17 in group D (placebo+hexachlorophene) (2 not streptococcal positive, 2 failed to return for first follow-up;), 6/22 in group E (bacitracin) (2 not streptococcal positive, 4 failed to return for first follow-up).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was no baseline imbalance. Compliance was good for penicillin (based on urine test) but not reported for other therapy.

Randomised?Low riskQuote: "Patients were assigned to one of five treatment groups by a random numbers list."

Were both inclusion and exclusion criteria specified?High riskQuote: "Children with... were excluded."

Quote: "All patients were seen".

Sutton 1992

MethodsTime NR; UK; general practice (n = 20); only impetigo (only facial)


Participants
  • 1 months to 77 years, average 22 years
  • M/F 84/93
  • S. aureus 68/177


PNE


InterventionsA: fusidic acid cream 3 td, 6 to 8 days
B: mupirocin ointment 3 td, 6 to 8 days


OutcomesOutcomes of the trial

1) 8 days, cure + improved


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was provided.

Allocation concealment (selection bias)Unclear riskInsufficient information was provided.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "Investigators were not aware of the treatment given until the study was completed."

Quote: "Treatment was allocated randomly in a double-blind manner, medication [was] dispensed in numbered, sealed containers." There was unclear blinding of the caregivers because it is unclear whether this is the same person as the outcome assessor. The participants were blinded.

Incomplete outcome data (attrition bias)
All outcomes
High risk24/201 were omitted in the analysis: 93 were left in the fusidic acid group, 84 were left in the mupirocin group (not further specified). 177/201 were in the analysis. Of the 24 participants who were not analysed for efficacy, 20 returned for follow-up after more than 8 days, 2 defaulted, and 2 violated the study protocol.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was no baseline imbalance. There were no compliance data.

Randomised?Low riskQuote: "Treatment was allocated randomly in a double-blind manner."

Were both inclusion and exclusion criteria specified?Low riskQuote: "A total of 201 patients requiring topical antibiotic treatment for facial impetigo were enrolled".

Quote: "Exclusion criteria were..."

Tack 1997

Methods1992 July to 1993 August; multicentre; US; outpatients; range of skin infections (including impetigo 225/394)


Participants
  • 0 to 13 years (median 5.4)
  • M/F 217/197
  • S. aureus 284/394 (all participants)


PE


InterventionsA: cefdinir 7 mg/kg/day , 2 td, 10 days
B: cephalexin 10 mg/kg/day, 4 td, 10 days


OutcomesOutcomes of the trial

1) 7 to 14 day, cure


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was provided.

Allocation concealment (selection bias)Unclear riskIt is unclear whether participants and investigators enrolling participants could foresee assignment.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "...a multicenter, randomized, controlled, investigator-blind..." Also, participants in both groups did not receive the same administrations of study drugs daily. The outcome assessor was blinded. The caregiver and participant were not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskQuote: "...number of patients excluded for each reason comparable among groups." The proportion of participants not evaluable for reasons of non-compliance was unclear.

Quote: "An intention-to-treat analysis was also performed. This analysis counted as failures all patients who had negative admission cultures or for whom follow-up information was not available."

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was no baseline imbalance (sex, age, race, infection type). There were no compliance data.

Randomised?Low riskQuote: "...a multicenter, randomized, controlled, investigator-blind..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Pediatric patients...were eligible for study entry."

Quote: "Patients were prohibited from entering the study if..."

Tack 1998

MethodsJanuary to December 1992; multicentre; USA; outpatients, range of skin infections (including impetigo 62/952)


Participants
  • 13 to 88 years
  • M/F 564/388 (all participants)
  • S. aureus 308/382 (all participants)


PE


InterventionsA: cefdinir caps 300 mg, 2 td, 10 days
B: cephalexin caps 500 mg, 4 td, 10 days


OutcomesOutcomes of the trial

1) 7 to 16 days, cure/improved


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was provided.

Allocation concealment (selection bias)Unclear riskInsufficient information was provided.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "This was a double-mask, comparative, multicenter study."

Quote: "Matched placebo capsules were dispensed appropriately to maintain study masking." It is not clear who was blinded (and how). It is unclear whether the outcome assessor and caregiver were blinded. The participants were blinded. 

Incomplete outcome data (attrition bias)
All outcomes
High risk952 randomised participants.

Quote: "Of these, 178 cefdinir patients and 204 cephalexin patients were considered microbiologically assessable and were included in the efficacy analyses." > 20% not included in efficacy analysis because they were not assessed or the study drug was not taken as prescribed (table III). There was no intention-to-treat analysis.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskGroups were similar at baseline (table II), though not specified for impetigo participants. There were no compliance data.

Randomised?Low riskQuote: "Patients were randomized 1:1 to receive..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Eligible patients were..."

Quote: "Exclusion criteria included..."

Tamayo 1991

MethodsTime NR; Mexico; outpatients; only impetigo


Participants
  • 6 months to 12 years, average 4 years 8 months
  • M/F 14/16
  • S. aureus 18/30, S. pyogenes 4/30, both 1/30


PE: not clear


InterventionsA: rifamycin spray, 2 td, 7 days
B: mupirocin ointment 2%, 2 td, 7 days


OutcomesOutcomes of the trial

1) 1 week, cure/improved


NotesBoth primary (n = 17) and secondary (n = 13) impetigo participants were studied.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskInsufficient information was available.

Blinding (performance bias and detection bias)
patient
High riskQuote: "...open trial". Also, spray versus ointment. The caregiver, outcome assessor, and participant were not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk0/30 participants were omitted in the analysis: 0/15 in the rifamycin group, 0/15 in the mupirocin group.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was no baseline imbalance. There were no compliance data.

Randomised?Low riskQuote: "...fueron asignados al azar." [...were assigned at random.]

Were both inclusion and exclusion criteria specified?Low riskQuote: "En este estudio únicamente se incluyeron pacientes con lesiones localizades, con área no mayor de 10 cm² Los criterios de exclusión fueron niños con lesiones con un tiempo de evolución mayor de un mes." [In this study, patients were only included if the lesions were smaller than 10 cm². Exclusion criteria were children with lesions present longer than 1 month].

Tassler 1993

MethodsTime NR; multicentre; Europe and South America; hospital-admitted and outpatients; range of skin infections (including impetigo 42/172)


Participants
  • Age 18 to 99 years
  • M/F 159/125 (all part)
  • S. aureus 58% (all participants)


PE


InterventionsA: fleroxacin 400 mg, 1 td, 7 to 21 days
B: amoxicillin/clavulanic acid tablets 500/125 mg, 3 td, 7 to 21 days


OutcomesOutcomes of the trial

1) 7 days, cure


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskInsufficient information was available

Blinding (performance bias and detection bias)
patient
High riskQuote: "...open-label". Participants in both groups did not receive the same administrations of study drugs daily. Also, investigators enrolling participants could possibly foresee assignment. The outcome assessor, caregiver, and participant were not blinded.

Incomplete outcome data (attrition bias)
All outcomes
High riskNot only impetigo - it was not specified how many impetigo participants were randomised and included. 27 were analysed in the fleroxacin group, 15 were analysed in the amoxicillin/clavulanic group. Further data was not specified for impetigo participants. Not all participants were assessable for the efficacy analysis, but it was not stated how many.

Selective reporting (reporting bias)Unclear riskThis was not unclear.

Other biasUnclear riskThere was no baseline imbalance. There were no compliance data.

Randomised?Low riskQuote: "This study was designed as a prospective, randomized, open label..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Inpatients or outpatients of either sex were eligible for inclusion in the study if..."

Quote: "Exclusion criteria were..."

Vainer 1986

MethodsMarch 1982 to January 1984; Denmark; general practice; only impetigo


Participants
  • Age 1 to 77, average 11 years
  • M/F 71/57
  • No bacterial culture done


PNE


Interventions3 arms:
A: fusidic acid cream 2%
B: tetracycline/polymyxin B ointment
C: neomycin/bacitracin ointment


OutcomesOutcomes of the trial

1) 1 week, cure/improved


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskInsufficient information was available.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "Undersøgelsen var således blindet for lægen, men ikke for patienten." [The study was blinded for the doctor, but not for the patient.] The outcome assessor and caregiver were blinded. Participants were not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk6/134 participants were not included in the analysis: unknown group assignment, reasons were given.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was no baseline imbalance for severity. The used medication is in table 2. There were no compliance data.

Randomised?Low riskQuote: "...randomiseringsnummer." [...randomisation number.]

Were both inclusion and exclusion criteria specified?Low riskQuote: "For at indgå i study skulle patienterne have klinisk verificeret impetigo"; "Udelukket var patienter med impetigeniserede eksemer, patienter med..." [Patients were eligible if they had clinical verified impetigo; Excluded were patients with impetiginised eczema and patients with...]

Wachs 1976

Methods1974; multicentre; USA; outpatients; only impetigo (secondary)


Participants
  • Age/sex NR
  • S. aureus 62/79


PNE


Interventions3 arms:
A: betamethasone valerate cream, 3 td
B: gentamycin cream, 3 td
C: betamethasone + gentamycin cream, 3 td


OutcomesOutcomes of the trial

1) 3 weeks, excellent result


NotesSecondary impetigo (impetiginised atopic dermatitis)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskInsufficient information was available

Blinding (performance bias and detection bias)
patient
Low riskQuote: "...precautions being observed to preserve the blinding of both patients and therapists." Also, participants in both groups received the same administrations of study drugs daily. The outcome assessor, caregiver, and participant were blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk4/83 participants were omitted in the analysis (not further specified).

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was a baseline comparison for severity and no imbalance. There were no compliance data.

Randomised?Low riskQuote: "Patients under the care of an individual investigator were randomly assigned."

Were both inclusion and exclusion criteria specified?Low riskQuote: "All patients enrolled were clinically judged to have moderate to severe impetiginized..."

Quote: "In order to be accepted for the study..."

Quote: " ...were excluded."

Wainscott 1985

MethodsTime NR; London, UK; outpatients and general practice; range of skin infections (including impetigo 16/39)


Participants
  • Age NR
  • M/F 25/14 (all participants)
  • S. aureus 31/48 (all participants)


PE: not clear


InterventionsA: mupirocin ointment 2%, 2 td, 7 to 14 days
B: chlortetracycline cream 3%, 2 td, 7 to 14 days


OutcomesOutcomes of the trial

1) 7 days, cure/improved


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskInsufficient information was available.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "Thirty-nine patients were entered in a randomized, observer-blind trail."

Quote: "...but the medications were packaged identically and not opened in the presence of the physician." The outcome assessor and caregiver were blinded. Participants were not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk3/39 participants were omitted in the analysis: 2/22 in the mupirocin group, 1/17 in the chlortetracycline group. These 3 were excluded from the analysis of results as they received systemic antibiotics for other infections while in the study.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere was a baseline imbalance for age (all infants were in the Bactroban group). This was not specified for impetigo. There were no compliance data.

Randomised?Low riskQuote: "Thirty-nine patients were entered in a randomized, observer-blind trail."

Were both inclusion and exclusion criteria specified?High riskQuote: "Patients with lesions suitable for treatment with a topical antibiotic were entered in the study." No exclusion criteria was specified.

Welsh 1987

MethodsTime NR; Monterrey, Mexico; outpatients; range of skin infections (including impetigo 15/60)


Participants
  • Age NR
  • M/F 32/28
  • S. aureus 47/50


PNE


InterventionsA: mupirocin ointment 2%, 3 td, 5 to 10 days
B: ampicillin 50 mg, 4 td, 5 to 10 days


OutcomesOutcomes of the trial

1) 10 days, cure/improved


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskInsufficient information was available.

Blinding (performance bias and detection bias)
patient
High riskQuote: "...in an open trial." Thereby, the participants in both groups did not receive the same administrations of study drugs daily. The outcome assessor, caregiver, and participant were not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low risk10/60 participants were omitted in the analysis: 5/32 in the mupirocin group were lost to follow up, 5/28 in the ampicillin group were lost to follow up. These 10 participants were not analysed.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskQuote: "Patient characteristics were similar in both treatment group in terms of sex, age, and weight." Table I shows no baseline imbalance for severity. There were no compliance data.

Randomised?Low riskQuote: "A randomized clinical trial..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "...outpatients with primary and secondary skin infections."

Quote: "Patients were excluded from entry into the trial on the basis of..."

White 1989

Methods1985 to 1987; UK; general practice; range of skin infections (including impetigo 155/390)


Participants
  • Age 11 months to 84 years
  • M/F NR
  • S. aureus 43% (all participants)


PNE


InterventionsA: mupirocin ointment 2%, 2 td, 7 days
B: fusidic acid ointment 2%, 3 td, 7 days


OutcomesOutcomes of the trial

1) 7 days, cure/improved


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Low riskQuote: "...and patients were randomised to receive treatment with either..."

Quote: "For this purpose, a code was designed in blocks of six..."

Quote: "The tubes were supplied in a sealed box labelled with the patient's number. Thereby the observer did not know which antibiotic a patient was receiving."

Comment: This was probably done.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "Four plain tubes containing the preparations were supplied for each patient. These were labelled with instructions for use but the name of the antibiotic was omitted. Mupirocin was to be applied twice daily and sodium fusidate thrice daily."

Quote: "The tubes were supplied in a sealed box labelled with the patient's number. Thereby the observer did not know which antibiotic a patient was receiving." The outcome assessor was blinded. The caregiver and participant were probably not blinded because they did not receive the same administrations of study drugs daily.

Incomplete outcome data (attrition bias)
All outcomes
High risk23/413 participants were omitted in the analysis: 12/275 in the mupirocin group (8 failed to attend for assessment, 1 withdrew due to revised diagnosis, 3 were prescribed antibiotics for reasons other than lack of efficacy), 11/138 in the sodium fusidate group (3 failed to attend for assessment, 1 withdrew due to revised diagnosis, 2 were prescribed antibiotics for reasons other than lack of efficacy, 4 due to non-compliance, 1 due to inadequate data). < 20% dropouts, but reasons were not balanced between the groups.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskQuote: "There was a similar distribution of type and severity of infection between the two treatment groups". There were no compliance data.

Randomised?Low riskQuote: "...observer-blind randomised multi-centre clinical trial."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Any patient with primary or secondary skin infection, other than...was eligible for entry."

Quote: "Patients were excluded if..."

Wilkinson 1988

MethodsTime NR; Quebec, Canada; outpatients; range of skin infections (including impetigo 10/50)


Participants
  • Age/sex NR
  • S. aureus 18/50 (all participants)


PE: not clear


InterventionsA: mupirocin 2%, 3 td, 7 days
B: polymyxin B-neomycin (Neosporin), 3 td, 7 days


OutcomesOutcomes of the trial

1) 7 days, cure/improved


Notes-


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information was available.

Allocation concealment (selection bias)Unclear riskInsufficient information was available.

Blinding (performance bias and detection bias)
patient
Unclear riskQuote: "...double-blind fashion." It was unclear how, and if, the outcome assessor, caregiver, and participant were blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low riskThere were 0/10 missing impetigo participants: 0/4 missing in the mupirocin group, 0/6 missing in the neosporin group.

Selective reporting (reporting bias)Unclear riskThis was unclear.

Other biasUnclear riskThere were no baseline characteristics. There were no compliance data.

Randomised?Low riskQuote: "...were randomly divided into..."

Were both inclusion and exclusion criteria specified?Low riskQuote: "Fifty patients who appeared at the dermatologic clinic with primary and secondary skin infections of...were randomly divided..."

Quote: "...were excluded from the trial."

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Alavena 1987Randomisation was inadequate.

Anonymous 1998Results were not separately described for impetigo participants: no randomisation.

Arata 1983Randomisation was inadequate (serial allocation).

Arata 1994The results were not separately described for impetigo participants.

Arosemena 1977The results were not separately described for impetigo participants: only 6/343 participants had impetigo.

Azimi 1999The results were not separately described for impetigo participants.

Baldwin 1981The same drug was compared.

Ballantyne 1982The results were not separately described for impetigo participants: no randomisation.

Bastin 1982The results were not separately described for impetigo participants.

Bernard 1997The results were not separately described for impetigo participants (requested, but no reply).

Bin Jaafar 1987No participants had impetigo ( "pyoderma").

Burnett 1963There was no randomisation.

Cassels-Brown 1981The design was unacceptable (no RCT).

Colin 1988The results were not separately described for impetigo participants.

Cordero 1976There was only 1 impetigo participant.

De Waard 1967There was no randomisation: 2 arms with the same active drug (though different mode of administration).

Dillon 1970There was no randomisation.

Dillon 1979aThe results were not separately described for impetigo participants.

Drehobl 1997The results were not separately described for impetigo participants (requested, but no reply).

el Mofty 1990The results were not separately described for impetigo participants.

Esterly 1970There was no randomisation.

Faingezicht 1992The results were not separately described for impetigo participants.

Fedorovskaia 1989Randomisation was inadequate.

Fleisher 1983The results were not separately described for impetigo participants.

Forbes 1952The same drug was compared.

Free 2006No participants had impetigo (communication: Nicole E. Scangarella).

Gentry 1985The results were not separately described for impetigo participants.

Gibbs 1987All impetigo participants received the same treatment.

Golcman 1997The results were not separately described for impetigo participants (requested, but no reply).

Goldfarb 1987The results were not separately described for impetigo participants.

Gooch 1991The results were not separately described for impetigo participants.

Hanfling 1992The results were not separately described for impetigo participants.

Harding 1970There was 1 drug (flucloxacillin) in 2 doses: the results for impetigo participants were not separately described.

Heskel 1992The results were not separately described for impetigo participants.

Jacobs 1992The results were not separately described for impetigo participants.

Jennings 1999There was only 1 impetigo participant.

Jennings 2003The results were not separately described for impetigo participants (requested, but no reply).

Keeny 1979The results were not separately described for impetigo participants.

Kotrajaras 1973The results were not separately described for impetigo participants.

Kumakiri 1988There was only 1 impetigo participant.

Kumar 1988No participants had impetigo: 2 forms of the same drug.

Lassus 1990The results were not separately described for impetigo participants.

Lentino 1984There was only 1 impetigo participant.

Levenstein 1982The results were not separately described for impetigo participants.

Lewis-Jones 1985The results were not separately described for impetigo participants.

Linder 1978The results were not separately described for impetigo participants.

Linder 1993The results were not separately described for impetigo participants.

Lipets 1987No comparison was made.

Liu 1986No participants had impetigo (impetigo herpetiformis).

MacKenna 1945Randomisation (serial allocation) was inadequate.

Macotela-Ruiz 1988The results were not separately described for impetigo participants (requested, but no reply).

Mallory 1991The results were not separately described for impetigo participants.

Manaktala 2009The results were not separately described for impetigo participants.

McCarty 1992The results were not separately described for impetigo participants.

McMillan 1969The results were not separately described for impetigo participants.

Milidiú d Silva 1985The results were not separately described for impetigo participants.

Nakayama 1983The results were not separately described for impetigo participants, and it was not an RCT.

Neldner 1991The results were not separately described for impetigo participants.

Nichols 1997The results were not separately described for impetigo participants.

Nicolle 1990The results were not separately described for impetigo participants.

Nolting 1992No participants had impetigo (pyoderma).

Orecchio 1986The results were not separately described for impetigo participants.

Pakrooh 1978No participants had impetigo.

Palazzini 1993The results were not separately described for impetigo participants.

Parish 1984The results were not separately described for impetigo participants.

Parish 1991The results were not separately described for impetigo participants.

Parish 1992The results were not separately described for impetigo participants.

Parish 1997The results were not separately described for impetigo participants.

Parish 2000The results were not separately described for impetigo participants (requested, but no data available).

Parish 2006No participants had impetigo (communication: Nicole E. Scangarella).

Park 1993There was no randomisation (personal communication: Seungsoo Sheen).

Pien 1983The results were not separately described for impetigo participants.

Powers 1991There were no separate results for clinical cure.

Powers 1993There were only 2 impetigo participants.

Pusponegoro 1990There was only 1 impetigo participant,

Risser 1985The results were not separately described for impetigo participants.

Saenz 1985The results were not separately described for impetigo participants.

Salzberg 1972There was only 1 impetigo participant.

Schupbach 1992The results were not separately described for impetigo participants.

Schwartz 1996There was only 1 impetigo participant.

Smith 1985The results were not separately described for impetigo participants.

Smith 1993There was only 1 impetigo participant.

Sobye 1966The results were not separately described for impetigo participants.

Stevens 1993There were 5 participants with "pyoderma".

Tack 1991The results were not separately described for impetigo participants, and the same drug was compared.

Török 2004The same drug was compared.

Urbach 1966No randomisation was described.

Van der Auwera 1985No participants had impetigo.

Villiger 1986The results were not separately described for impetigo participants.

Wachs 1992The results were not separately described for impetigo participants.

Wible 2003The results were not separately described for impetigo participants (requested, but no reply).

Wolbling 19872 doses of 1 drug were compared.

Wong 1989The results were not separately described for impetigo participants.

Yura 1988The results were not separately described for impetigo participants.

 
Characteristics of studies awaiting assessment [ordered by study ID]
Chen 2011

MethodsThis is an RCT.

Participants
  • Age 6 months to 18 years with uncomplicated skin and soft tissue infections

InterventionsIntervention

A: clindamycin

Control intervention

B: cephalexin

OutcomesPrimary outcomes of the trial

1) Improvement

Secondary outcomes of the trial

1) Complete resolution

NotesThis is a result of the CSG searches that were run in August 2011.
It is not known how many participants were impetigo patients.

Chosidow 2005

MethodsThis is an RCT.

Participants
  • Various skin infections (including impetigo)

InterventionsIntervention

A: cloxacillin

Control intervention

B: pristinamycin

OutcomesOutcomes of the trial

1) Cure

NotesThis will be included when data on impetigo participants is provided.

Davies 1945

MethodsPlease see the 'notes' cell below.

ParticipantsPlease see the 'notes' cell below.

InterventionsPlease see the 'notes' cell below.

OutcomesPlease see the 'notes' cell below.

NotesThis is a result of the CSG searches that were run in August 2011.

We were unable to obtain a copy of this trial.

Ghosh 1995

MethodsThis is possibly an RCT.

Participants
  • 70 participants of different ages suffering from pyoderma, including infective dermatitis of which 30 participants had impetigo

InterventionsIntervention

A: neem, haldi, sajina, and garlic oil (Nutriderm oil)

Control intervention

B: gentian violet

OutcomesPrimary outcomes of the trial

1) Cure

Secondary outcomes of the trial

1) Side-effects

Notes-

Gubelin 1993

MethodsPlease see the 'notes' cell below.

ParticipantsPlease see the 'notes' cell below.

InterventionsPlease see the 'notes' cell below.

OutcomesPlease see the 'notes' cell below.

NotesThis paper was published in Spanish, and we were unable to obtain a copy.

Kar 1988

MethodsThis is possibly an RCT.

Participants
  • 200 children suffering from various types of pyoderma, 94 of which had impetigo

InterventionsIntervention

A: injection benzathine penicillin

Control intervention

B: oral sulphamoxole

OutcomesOutcomes of the trial

1) Cure after 1 and 2 weeks

NotesThere did not appear to be separate results for impetigo.

Kar 1996

MethodsThis is possibly an RCT.

Participants
  • 200 children aged 10 months to 12 years suffering from pyoderma

InterventionsIntervention

A: 125 mg amoxicilin plus 30 mg clavulanate per 5 ml of suspension, equivalent to 20 mg amoxicillin/kg/day in 3 divided doses

Control interventions

B: amoxicillin 20 mg/kg/day in 3 divided doses

C: erythromycin 30 mg/kg/day in 4 divided doses

D: co-trimoxazole (8 mg trimethoprim + 40 mg sulfamethoxazole/kg/day) in 2 divided dosis

OutcomesPrimary outcomes of the trial

1) Presence of S. aureus

Secondary outcomes of the trial

1) Cure

2) Adverse events

NotesIt was not clear if pyoderma equated to impetigo.

Luby 2002

MethodsThis is an RCT.

Participants
  • 162 households in Pakistan

InterventionsIntervention

A: 1.2% triclocarban-containing soap

Control intervention

B: an identically appearing placebo

OutcomesOutcomes of the trial

1) Impetigo incidence

NotesThis is a result of the CSG searches that were run in August 2011.

Menendez 2007

MethodsThis is possibly an RCT.

Participants
  • 136 children (1 day to 14 years) with impetigo

InterventionsIntervention

A: sunflower oil

Control intervention

B: mupirocin

OutcomesPrimary outcomes of the trial

1) Clinical cure after possibly 6 days

NotesThis paper was written in Spanish.

Motohiro 1992

MethodsThis is an RCT.

ParticipantsPlease see the 'notes' cell below.

InterventionsPlease see the 'notes' cell below.

OutcomesPlease see the 'notes' cell below.

NotesThis is a result of the CSG searches that were run in August 2011.
We were unable to obtain a copy of this trial.

Pierard-Franchimont 2008

MethodsThis is an RCT.

ParticipantsPlease see the 'notes' cell below.

InterventionsPlease see the 'notes' cell below.

OutcomesPlease see the 'notes' cell below.

NotesThis is a result of the CSG searches that were run in August 2011.

We were unable to obtain a copy of this trial.

Sharquie 2000

MethodsThis is possibly an RCT.

Participants
  • 104 participants with impetigo

InterventionsIntervention

A: tea lotion

B: tea ointment

C: soframycin

D: oral cephalexin

OutcomesPrimary outcomes of the trial

1) Cure after 7 to 10 days

Notes-

Suchmacher 2010

MethodsThis is an RCT.

ParticipantsPlease see the 'notes' cell below.

InterventionsPlease see the 'notes' cell below.

OutcomesPlease see the 'notes' cell below.

NotesThis is a result of the CSG searches that were run in August 2011.

We were unable to obtain a copy of this trial.

Tong 2010

MethodsThis is a pilot study.

Participants
  • 13 participants with skin sores

InterventionsIntervention

A: oral cotrimoxazole

B: intramuscular benzathine penicillin

OutcomesPrimary outcomes of the trial

1) Resolution of skin sores

NotesAustralian Trial Register: Is cotrimoxazole safe and efficacious for treatment of skin sores in Aboriginal children: a pilot study

Published in the Journal of Pediatrics and Child Health 2010;46:131-133

Wang 1988

MethodsThis is possibly an RCT.

ParticipantsPlease see the 'notes' cell below.

InterventionsPlease see the 'notes' cell below.

OutcomesPlease see the 'notes' cell below.

NotesWe were unable to obtain a copy of this trial.

Wang 1995

MethodsThis is possibly an RCT.

ParticipantsPlease see the 'notes' cell below.

InterventionsPlease see the 'notes' cell below.

OutcomesPlease see the 'notes' cell below.

NotesWe were unable to obtain a copy of this trial.

 
Characteristics of ongoing studies [ordered by study ID]
ACTRN12609000858291

Trial name or titleAn open label randomised controlled trial to determine if 5 days of once-daily oral trimethoprim-sulfamethoxazole or three days of twice-daily oral trimethoprim-sulfamethoxazole will lead to non-inferior cure rates of impetigo compared to a single dose of intramuscular benzathine penicillin G (the current gold standard treatment) in children living in remote Aboriginal communities between the age of 12 weeks to less than 13 years

MethodsSee title.

ParticipantsInclusion criteria of the trial

1. Age 12 weeks to less than 13 years at the time written consent is obtained
2. Diagnosis of purulent or crusted impetigo by criteria outlined in the Booklet "Recognising and Treating Skin Conditions" (East Arnhem Healthy Skin Program (EAHSP), Menzies School of Health Research 2006)
3. A resident in 1 of the participating (Aboriginal) communities at the time of enrolment and intending to stay in that community for the duration of the study (7 days post-randomisation)

InterventionsGroup 1: single dose intramuscular benzathine penicillin G - weight band-based dosing up to 900 mg (> 3 and < 6 kg = 225 mg; > 6 and < 10 kg = 337.5 mg; > 10 and < 15 kg = 450 mg; > 15 and < 20 kg = 675 mg; > 20 kg = 900 mg)

Group 2: trimethoprim-sulfamethoxazole oral suspension 8 + 40 mg/kg (max 320 + 1600 mg) daily for 5 days

Group 3: trimethoprim-sulfamethoxazole oral suspension 4 + 20 mg/kg (max 160 + 800 mg) twice daily for 3 days

OutcomesPrimary outcomes of the trial

1) The proportion of children successfully treated on day 7 after the commencement of treatment within each of the respective groups. Successfully treated is defined as a child with impetigo which has been clinically classified as sore either healed or improved by a person blinded to the allocated randomisation

Secondary outcomes of the trial

1) The proportion of children within each of the respective groups who are defined as being successfully treated on day 2 

2) Prevalence of Staphylococcus aureus (methicillin susceptible and methicillin resistant) and Group A Streptococci per child at day 0, day 2, and day 7 within each treatment group as determined from impetigo swabs collected at the respective time points 

3) Effect of each treatment on the bacterial resolution of sores at days 2 and 7 as determined by impetigo swabs collected at the respective time points 

4) Prevalence of nasal carriage of Staphylococcus aureus at baseline and day 7 (including a comparison of the prevalence of methicillin-resistant S. aureus at baseline and day 7)

5) Evidence of allergy or other reaction to the medication within 7 days of first administration as determined by clinical observation and questioning of caregivers 

Starting date1st December 2009

Contact informationRoss Andrews (ross.andrews@menzies.edu.au)
Menzies School of Health Research
PO Box 41096 Casuarina, 0811, NT, Australia

NotesAustralian New Zealand Clinical Trial Registry: ACTRN12609000858291

CTRI/2008/091/000060

Trial name or titleAn Open Labelled, Double Arm, Randomized, Multicentric, Prospective And Comparative, Phase-III Trial To Evaluate The Safety And Efficacy Of Fixed Dose Combination Of Ceftriaxone And Vancomycin Injection Vs. Vancomycin Injection In Subjects With Various Bacterial Infections

MethodsSee above.

ParticipantsInclusion criteria of the trial

  • All subjects aged between 18 and 70 years
  • Diagnosed subjects of infectious disease (on clinical evaluation).
  • Subjects willing to give informed consent
  • Subject suffering from any of the following infections - lower respiratory tract infections, skin and skin structure infections, endocarditic, bacterial meningitis and bone infection

InterventionsSee above.

OutcomesPrimary outcomes of the trial

1) Compare the efficacy of a 3.0 g FDC of ceftriaxone and vancomycin injection vs 1.0 g vancomycin injection in subjects with mild to severe bacterial infections

Secondary outcomes of the trial

1) Evaluate the safety of the test and comparative product

Starting date8th April 2008

Contact informationkundan.k@nexuscro.com

NotesIt is unclear whether impetigo participants will be included.

NCT00202891

Trial name or titleSisomicin Cream Vs Nadifloxacin Cream in Primary Pyodermas

MethodsThis was to be a randomised, active-control trial.

End point classification - safety/efficacy study

Intervention model - parallel assignment

Masking - open-label

Primary purpose - treatment

ParticipantsInclusion criteria of the trial

  • Participants of either sex, suffering from primary pyodermas requiring topical antibiotic therapy without occlusive dressing, > = 6 years of age
  • Written informed consent

InterventionsSee title.

OutcomesNone were stated.

Starting dateMay 2007

Contact informationRagunandan Torsekar, MD, FCPS (Principal Investigator)

Rajiv Gandhi Medical College

NotesThe current status of the trial is withdrawn (NCT00202891).

NCT00626795

Trial name or titleEfficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)

MethodsQuote: "This is an international, multicentre, prospective 3-arm parallel-group, phase II proof of concept study comparing the efficacy and safety of 2 dosage regimens (BID 7 days and TID 7 days) of TD1414 2% cream and 1 dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2% cream in adults and children down to 2 years of age with impetigo or SITL. Furthermore, an evaluation of the pharmacokinetics of TD1414 2% cream TID for 7 days will be performed. A total of 664 patients will be enrolled in a stepwise manner according to age groups starting with the oldest age group."

ParticipantsSee above.

InterventionsSee above.

OutcomesPrimary outcomes of the trial

1) Clinical cure at end of treatment according to investigator's assessment

Secondary outcomes of the trial

1) Clinical cure at follow-up according to investigator's assessment

2) Clinical cure at end of treatment and follow-up according to investigator's assessment

3) Bacteriological cure at end of treatment and follow-up

Starting dateFebruary 2008

Contact informationAlmena L Free, MD (Principal Investigator)

Anniston Medical Clinic

Anniston, Alabama, United States 36207

Noteswww.clinicaltrials.gov

NCT00852540

Trial name or titleA Randomized, Double-Blind, Double Dummy, Comparative, Multicenter Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, Versus Oral Linezolid in the Treatment of Secondarily-Infected Traumatic Lesions and Impetigo Due to Methicillin-Resistant Staphylococcus Aureus

MethodsSee above.

ParticipantsSee above.

InterventionsSee above.

OutcomesPrimary outcomes of the trial

1) Number of participants achieving clinical response at follow-up who had methicillin-resistant Staphylococcus aureus (MRSA) as a baseline pathogen

Secondary outcomes of the trial

1) Number of participants achieving microbiological response at follow-up who had MRSA as a baseline pathogen

2) Number of participants with clinical response at follow-up

3) Number of participants who achieved microbiological response at follow-up who had a baseline pathogen

4) Number of participants with the indicated clinical outcome at the end of therapy who had MRSA as a baseline pathogen

5) Number of participants with the indicated microbiological outcome at the end of therapy who had MRSA as a baseline pathogen

6) Number of participants with the indicated clinical outcome at the end of therapy

7) Number of baseline pathogens with the indicated microbiological outcome at the end of therapy

8) Number of participants with therapeutic response at follow-up

9) Mean scores on the skin infection rating scale at visits 1, 2, 3, 4, and 5

10) Mean wound size at visits 1, 2, 3, 4, and 5

Starting dateApril 2009

Contact informationStudy Director

GSK Clinical Trials

GlaxoSmithKline

Notes-

NCT00986856

Trial name or titleA Phase IV Study Comparing Clinical and Bacteriological Efficacy of Fucidin® Cream With Fucidin® Cream Vehicle in the Treatment of Impetigo in Paediatric Patients

MethodsThis is a randomised, placebo-controlled trial.

End point classification - safety/efficacy Study

Intervention model: parallel assignment

Masking - double-blind (subject, investigator)

Primary purpose - treatment

ParticipantsInclusion criteria of the trial

  • Participants with a clinical diagnosis of impetigo
  • Participants aged 2 to 11 years
  • Participants of either sex
  • Participants whose parent(s) has/have provided written consent
  • Participants with a severity score of 1 for at least 1 of the following signs: pustules/infected bullae, erythema, or infiltration/induration

InterventionsA: Fucidin® cream versus Fucidin® cream vehicle

OutcomesPrimary outcomes of the trial

1) The proportion of participants with clinical success (marked improvement or completely cleared) and bacteriological success (eradication) at end of treatment (EOT)

Secondary outcomes of the trial
1) The proportion of participants with clinical and bacteriological success at visit 2 and 3, and at EOT
2) The actual change in Total Severity Score from baseline to end of treatment
3) The distribution of individual sign scores at end of treatment

Starting dateMay 2004

Contact informationInga Odenholt (Principal Investigator)

Malmö University Hospital

NotesInfomation was obtained from clinicaltrials.gov. Information was requested in August 2010.

NCT01171326

Trial name or titleA Randomized, Parallel-group, Double Blind, Clinical Trial, to Asses the Safety and Efficacy of Topically Applied FXFM244 Antibiotic Foam in the Treatment of Impetigo

MethodsThis is a randomised, parallel-group, double (Investigator, participant)-blind, comparative dose range-finding clinical trial.

ParticipantsInclusion criteria of the trial

  • Participants with clinical diagnosis of pure impetigo, impetigo contagiosa, or uncomplicated blistering impetigo
  • Participants 2 years of age or older and in general good health
  • Participants with no less than 2 lesions and no more than 7 lesions (area 0.5 x 0.5 cm)
  • No known medical conditions that, in the Investigator's opinion, could interfere with study participation
  • Participant/participant's guardian (in the case of children) willing and able to comply with all requirements of the protocol
  • Participant/participant's guardian willing and able to give written informed consent prior to participation in the study

InterventionsThe study will involve 2 treatment groups.

A: Eligible participants will be randomised to receive either FXFM244 - 1% or FXFM244 - 4% in a blinded fashion. Participants will be treated twice daily for 7 days. Following the screening period and baseline visit, study subjects will return at days 3, 7 and 14. At each visit, participants will be evaluated via lesion count, global assessment tolerability, and safety.

OutcomesPrimary outcomes of the trial

1) Decrease in lesion count 7 days

Secondary outcomes of the trial

1) The severity of the overall impetigo condition will be measured at baseline and at all follow-up visits. The severity will be assessed and graded based on the scales for Investigator's Global Assessment and bacteriological testing (days 3, 7, and 14)

Starting dateAugust 2010

Contact informationFoamix Ltd.

Lev Yasmin Clinic
Natanya, Israel

NotesThis study is probably not eligible for inclusion as 2 dosages of the same drug are used.

 
Comparison 1. Non-bullous impetigo: topical (Top) antibiotic (Ab) vs placebo (P)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure/improvement6575Risk Ratio (M-H, Random, 95% CI)2.24 [1.61, 3.13]

    1.1 Mupirocin
3173Risk Ratio (M-H, Random, 95% CI)2.18 [1.58, 3.00]

    1.2 Fusidic acid
1156Risk Ratio (M-H, Random, 95% CI)4.42 [2.39, 8.17]

    1.3 Bacitracin
136Risk Ratio (M-H, Random, 95% CI)3.71 [0.16, 85.29]

    1.4 Retapamulin
1210Risk Ratio (M-H, Random, 95% CI)1.64 [1.30, 2.07]

 
Comparison 2. Non-bullous impetigo: topical (Top) antibiotic (Ab) vs another topical (Top) antibiotic (Ab)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure/improvement14Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 Mupirocin vs rifamycin
117Risk Ratio (M-H, Fixed, 95% CI)1.72 [0.96, 3.07]

    1.2 Mupirocin vs neomycin
132Risk Ratio (M-H, Fixed, 95% CI)1.29 [0.98, 1.71]

    1.3 Mupirocin vs bacitracin
116Risk Ratio (M-H, Fixed, 95% CI)2.57 [0.97, 6.80]

    1.4 Mupirocin vs chlortetracycline
114Risk Ratio (M-H, Fixed, 95% CI)1.11 [0.78, 1.59]

    1.5 Mupirocin vs polymyxin B/neomycin
18Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.56, 2.01]

    1.6 Fusidic acid vs neomycin/bacitracin
184Risk Ratio (M-H, Fixed, 95% CI)0.92 [0.66, 1.27]

    1.7 Fusidic acid vs tetracycline/polymyxin B
187Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.75, 1.52]

    1.8 Retapamulin vs fusidic acid
1517Risk Ratio (M-H, Fixed, 95% CI)1.05 [1.00, 1.11]

    1.9 Sulcanozol vs miconazole
166Risk Ratio (M-H, Fixed, 95% CI)5.31 [0.66, 43.04]

    1.10 Hydrocortisone + hydroxyquinoline vs hydrocortisone + miconazole
143Risk Ratio (M-H, Fixed, 95% CI)2.06 [0.89, 4.76]

    1.11 Gentamycin vs neomycin
1128Risk Ratio (M-H, Fixed, 95% CI)1.43 [1.03, 1.98]

    1.12 Mupirocin vs fusidic acid
4440Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.95, 1.11]

 
Comparison 3. Non-bullous impetigo: topical (Top) antibiotic (Ab) vs oral (Or) antibiotic (Ab)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure/improvement15Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 Mupirocin vs erythromycin
10581Risk Ratio (M-H, Fixed, 95% CI)1.07 [1.01, 1.13]

    1.2 Mupirocin vs dicloxacillin
153Risk Ratio (M-H, Fixed, 95% CI)1.04 [0.94, 1.15]

    1.3 Mupirocin vs cephalexin
117Risk Ratio (M-H, Fixed, 95% CI)0.95 [0.66, 1.37]

    1.4 Mupirocin vs ampicillin
113Risk Ratio (M-H, Fixed, 95% CI)1.78 [0.65, 4.87]

    1.5 Bacitracin vs erythromycin
130Risk Ratio (M-H, Fixed, 95% CI)0.5 [0.22, 1.11]

    1.6 Bacitracin vs penicillin
134Risk Ratio (M-H, Fixed, 95% CI)0.38 [0.04, 3.25]

    1.7 Bacitracin vs cephalexin
119Risk Ratio (M-H, Fixed, 95% CI)0.37 [0.14, 0.95]

 2 Cure/improvement2137Risk Ratio (M-H, Random, 95% CI)1.12 [0.86, 1.46]

    2.1 Mupirocin vs erythromycin: observer blinded studies
2137Risk Ratio (M-H, Random, 95% CI)1.12 [0.86, 1.46]

 
Comparison 4. Non-bullous impetigo: topical (Top) antibiotic (Ab) vs disinfecting treatments (Dt)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure/improvement2292Risk Ratio (M-H, Fixed, 95% CI)1.15 [1.01, 1.32]

    1.1 Bacitracin vs hexachlorophene
136Risk Ratio (M-H, Fixed, 95% CI)3.71 [0.16, 85.29]

    1.2 Fusidic acid vs hydrogen peroxide
1256Risk Ratio (M-H, Fixed, 95% CI)1.14 [1.00, 1.31]

 
Comparison 5. Non-bullous impetigo: topical (Top) antibiotic (Ab) vs antifungal (Af)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Mupirocin vs terbinafine
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 6. Non-bullous impetigo: topical (Top) antibiotic (Ab) + oral (Or) antibiotic (Ab) vs topical (Top) antibiotic (Ab) + oral (Or) antibiotic (Ab)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Tetracyclin + cefdinir vs tetracyclin + minomycin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.2 Tetracyclin + cefdinir vs tetracyclin + fosfomycin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.3 Tetracyclin + minomycin vs tetracyclin + fosfomycin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 7. Non-bullous impetigo: topical (Top) antibiotic (Ab) vs topical (Top) antibiotic (Ab) + oral (Or) antibiotic (Ab)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 Tetracyclin vs tetracyclin + cefdinir
134Risk Ratio (M-H, Fixed, 95% CI)1.57 [0.69, 3.58]

    1.2 Tetracyclin vs tetracyclin + minomycin
133Risk Ratio (M-H, Fixed, 95% CI)0.85 [0.62, 1.15]

    1.3 Tetracyclin vs tetracyclin + fosfomycin
138Risk Ratio (M-H, Fixed, 95% CI)1.31 [0.76, 2.25]

 
Comparison 8. Non-bullous impetigo: oral (Or) antibiotics (Ab) vs placebo (P)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure/improvement1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Penicillin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 9. Non-bullous impetigo: oral (Or) antibiotic (Ab) (cephalosporin) vs another oral (Or) antibiotic (Ab)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure/improvement6Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Cephalexin vs penicillin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.2 Cephalexin vs erythromycin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.3 Cephalexin vs azithromycin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.4 Cefaclor vs azithromycin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.5 Cefaclor vs amoxicillin/clavulanic acid
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.6 Cefadroxil vs penicillin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.7 Cefadroxil vs flucloxacillin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 10. Non-bullous impetigo: oral (Or) cephalosporin vs other oral (Or) cephalosporin

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure/improvement7Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 Cephalexin vs cefadroxil
196Risk Ratio (M-H, Fixed, 95% CI)0.99 [0.88, 1.12]

    1.2 Cephalexin vs cefdinir
3201Risk Ratio (M-H, Fixed, 95% CI)0.95 [0.88, 1.03]

    1.3 Cefaclor vs cefdinir
113Risk Ratio (M-H, Fixed, 95% CI)0.64 [0.23, 1.82]

    1.4 Cefditoren vs cefuroxime
158Risk Ratio (M-H, Fixed, 95% CI)0.73 [0.55, 0.97]

    1.5 Cefditoren vs cefadroxil
174Risk Ratio (M-H, Fixed, 95% CI)1.02 [0.78, 1.33]

 
Comparison 11. Non-bullous impetigo: oral (Or) macrolide vs penicillin

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure/improvement7363Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.98, 1.15]

    1.1 Erythromycin vs penicillin V
279Risk Ratio (M-H, Fixed, 95% CI)1.29 [1.07, 1.56]

    1.2 Erythromycin vs dicloxacillin
158Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.94, 1.13]

    1.3 Erythromycin vs amoxicillin
1129Risk Ratio (M-H, Fixed, 95% CI)1.00 [0.89, 1.13]

    1.4 Azithromycin vs cloxacillin
116Risk Ratio (M-H, Fixed, 95% CI)1.4 [0.57, 3.43]

    1.5 Azithromycin vs flucloxacillin/dicloxacillin
139Risk Ratio (M-H, Fixed, 95% CI)0.84 [0.61, 1.16]

    1.6 Clindamycin vs dicloxacillin
142Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.80, 1.27]

 
Comparison 12. Non-bullous impetigo: oral (Or) macrolide vs another oral (Or) macrolide

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure/improvement1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Azithromycin vs erythromycin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 13. Non-bullous impetigo: oral (Or) penicillin vs other oral (Or) antibiotic (Ab) (including penicillin)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure/improvement4Risk Ratio (M-H, Random, 95% CI)Subtotals only

    1.1 Amoxicillin + clavulanic acid vs amoxicillin
144Risk Ratio (M-H, Random, 95% CI)1.4 [1.04, 1.89]

    1.2 Amoxicillin + clavulanic acid vs fleroxacin
142Risk Ratio (M-H, Random, 95% CI)1.14 [0.80, 1.62]

    1.3 Cloxacillin vs penicillin
2166Risk Ratio (M-H, Random, 95% CI)1.59 [1.21, 2.08]

 
Comparison 14. Non-bullous impetigo: other comparisons of oral (Or) antibiotics (Ab)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure/improvement2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Lomefloxacin vs norfloxacin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.2 Fusidic acid vs pristinamycin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 15. Non-bullous impetigo: oral (Or) antibiotics (Ab) vs disinfecting treatments (Dt)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure/improvement1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Penicillin vs hexachlorophene
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 16. Bullous impetigo: topical (Top) antimicrobial vs placebo (P)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cured/improved after 3 to 4 days1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Eksalb vs placebo
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 17. Bullous impetigo: topical (Top) antibiotic (Ab) vs another topical (Top) antibiotic (Ab)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure/improvement1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Fusidic acid vs neomycin/bacitracin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.2 Fusidic acid vs chloramphenicol
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.3 Chloramphenicol vs neomycin/bacitracin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 18. Bullous impetigo: topical (Top) antibiotic (Ab) vs oral (Or) antibiotic (Ab)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure/improvement1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 Fusidic acid vs erythromycin
124Risk Ratio (M-H, Fixed, 95% CI)1.43 [0.83, 2.45]

    1.2 Neomycin/bacitracin vs erythromycin
124Risk Ratio (M-H, Fixed, 95% CI)0.14 [0.02, 0.99]

    1.3 Chloramphenicol vs erythromycin
124Risk Ratio (M-H, Fixed, 95% CI)0.29 [0.07, 1.10]

 
Comparison 19. Bullous impetigo: oral (Or) antibiotic (Ab) vs another oral (Or) antibiotic (Ab)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure/improvement1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Cephalexin vs dicloxacillin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 20. Secondary impetigo: topical (Top) antibiotic (Ab) vs oral (Or) antibiotic (Ab)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure/improvement1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Mupirocin calcium vs cephalexin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 21. Secondary impetigo: steroid (S) vs antibiotic (Ab)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure/improvement1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Betamethasone vs gentamycin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 22. Secondary impetigo: steroid (S) + antibiotic (Ab) vs steroid (S)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure/improvement1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Betamethasone + gentamycin vs betamethasone
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 23. Secondary impetigo: steroid (S) + antibiotic (Ab) vs antibiotic (Ab)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure/improvement1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Betamethasone + gentamycin vs gentamycin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 24. Secondary impetigo: oral (Or) antibiotic (Ab) vs another oral (Or) antibiotic (Ab)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Cure/improvement1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Cephalexin vs enoxacin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Table 1. Adverse events

StudyAdverse events: nature and number or percentage by treatment group

Arata 1989a; Arata 1989bmainly gastrointestinal: cefdinir 9/142, cefaclor 4/145

Arredondo 1987mupirocin: nil reported
dicloxacillin: abdominal pain 1/ 31, vomiting 2/31

Barton 1987not reported

Barton 1988abdominal pain: erythromycin 1/ 49, dicloxacillin 1/51
vomiting + rash: dicloxacillin 1/51

Barton 1989gastrointestinal: erythromycin 8/48, mupirocin 4/49

Bass 1997not reported

Beitner 1996diarrhoea: cefadroxil 14/327, flucloxacillin 87/324 (all participants)
severe (stomach ache/rash/fever/vomiting): cefadroxil 14/327, flucloxacillin 2/234 (all participants)

Blaszcyk 1998mainly gastro-intestinal (half of which were considered treatment-related): clindamycin 150 mg (19%), clindamycin 300 mg (17%), dicloxacillin 10% (all participants)

Britton 1990minor gastrointestinal: 11 total, equally divided

Bucko 2002a; Bucko 2002bunclear and not specified for impetigo participants

Christensen 1994led to withdrawal: skin irritation 1, burning 1, blistering 1 (all fusidic acid - hydrogen peroxide: 0)

mild SE: fusidic acid 9, hydrogen peroxide 13

Ciftci 2002burning, stinging, itching: 1 in each group

rash: 1 in terbinafine group

Claudy 2001upper gastrointestinal: fusidic acid 6.8% vs pristinamycin 11.6%

lower gastrointestinal: 2.5% vs 16.7%

hypersensibility: 1.9% vs 5.8%

Dagan 1989vomiting: amoxicillin 1, amoxicillin and clavulanic acid (augmentin) 0

diarrhoea: amoxicillin 1, amoxicillin and clavulanic acid (augmentin) 0

Dagan 1992gastrointestinal: erythromycin 11/47, mupirocin 4/51

Daniel 1991a; Daniel 1991bno subgroup data

Demidovich 1990nil reported

Dillon 1983not reported

Dux 1986pruritus: mupirocin 1/78

nausea and abdominal pain: erythromycin 1/50, cloxacillin 0/20 (all participants)

Eells 1986not reported

Esterly 1991mupirocin: nil reported

erythromycin: stomach pain and nausea 1/20, vomiting and irritability 1/20, hysterical attacks 1/20

Farah 1967not reported

Faye 2007diarrhoea: amoxicillin 2/64 vs erythromycin 11/65

Fujita 1984mainly gastrointestinal: enoxacin 11/113, cephalexin 4/110 (all participants)

Gilbert 1989nil reported

Ginsburg 19781 child removed from cefadroxil group because of vomiting; no other SE reported

Giordano 2006diarrhoea: cefdinir 10% vs cephalexin 4%

nausea: cefdinir 3% vs cephalexin 6%

vaginal mycose of females: cefdinir 3% vs cephalexin 6%

Goldfarb 1988mild diarrhoea: amupirocin 0/30, erythromycin 5/30

Gonzalez 1989not reported

Gould 1984not reported

Gratton 1987mostly gastrointestinal: erythromycin 8/29

mupirocin: nil reported

Hains 1989nil reported

Ishii 1977nil reported

Jaffe 1985mild diarrhoea: Augmentin® 2/18, cefaclor 5/16 (all participants)

Jaffe 1986mild staining: hydrocortisone + potassium hydroxyquinoline sulphate cream 2/24, 1% hydrocortisone + 2% miconazole nitrate cream 0/24

Kennedy 1985nil reported

Kiani 1991mainly gastrointestinal: azithromycin 30/182, cephalexin: 20/184

Withdrawn: azithromycin 5 (4 gastrointestinal; 1 dizziness and somnolence), cephalexin 1(euphoria) (all participants)

Koning 2003mainly pain and burning due to povidone iodine: fusidic acid 7/76, placebo 19/80

Koning 2008any: retapamulin 15/139 vs placebo 2/71

application site pruritis: 9 vs 1

Koranyi 1976mild abdominal cramps: erythromycin 2/15, bacitracin 0/15

Kuniyuki 2005not reported

McLinn 1988gastrointestinal: mupirocin 0/30, erythromycin 6/30

Mertz 1989nil reported

Montero 1996mild skin side-effects: azythromycin 3/100, cefaclor 2/100

Moraes Barbosa 1986not reported

Morley 1988all local skin reactions: sodium fusidate 2/191, mupirocin 12/163 (all participants)

Nolting 1988mild burning: sulconazole 0/32, miconazole 1/34

Oranje 2007local irritation: retapamulin 6/346 vs sodium fusidate 0/173

Pruksachat 1993not reported

Rice 1992stomach ache/diarrhoea/vomiting/itching/burning (%): erythromycin 24/10/7/5/0, mupirocin 2/2/0/12/10

Rist 2002diarrhoea: mupirocin 2/82 vs cephalexin 3/77

Rodriguez-Solares 1993gastrointestinal: azithromycin 2/25, dicloxacillin/flucloxacillin 2/14

Rojas 1985nausea/vomiting: mupirocin 0/52, vehicle 1/52

Ruby 1973not reported

Sutton 1992local: fusidic acid 2/104, mupirocin 4/97

Tack 1997mainly gastrointestinal: cefdinir 16%, cephalexin 11% (all participants)

Tack 1998no subgroup data was available; it included only participants that had pathogens susceptible to both study drugs

Tamayo 1991nil reported

Tassler 1993mainly gastrointestinal: fleroxacin 17%, amoxicillin/clavunalate 21% (all participants)

Vainer 1986total 3%

skin rash: fusidic acid 1/43

burning and itching: tetracycline/polymyxin B ointment and neomycin/bacitracin ointment both 1/44 and 1/41 respectively

Wachs 1976not reported

Wainscott 1985nil reported

Welsh 1987nil reported

White 1989minor itching or burning: mupirocin 6/263, fusidic acid 2/127 (all participants)

Wilkinson 1988rash: mupirocin 0/24, neomycin 1/26 (all participants)

 
Table 2. Declared sponsorship or funding

StudySponsor (product)

Barton 1987Fleur de Lis Foundation

Barton 1988Warner-Lambert Corporation

Barton 1989Warner- Lambert Corporation

Beitner 1996Bristol-Myers Squibb (cefadroxil)

Blaszcyk 1998Pharmacia & Upjohn Asia (clindamycin)

Britton 1990US Navy Bureau of Medicine and Surgery Clinical Investigation Program

Bucko 2002a, Bucko 2002bTAF Pharmaceutical Products (cefditoren)

Daniel 1991a; Daniel 1991bPfizer Central Research (azithromycin)

Dillon 1983Eli Lilly Research (cephalexin)

Giordano 2006Abott Laboratories (cefdinir)

Goldfarb 1988Beecham Laboratories (mupirocin)

Hains 1989Bristol-Myers Squibb (cefadroxil)

Jaffe 1985Beecham Laboratories (amoxicillin+clavulanic acid)

Koning 2003Dutch College of General Practitioners

Koning 2008GlaxoSmithKline (retapamulin)

Mertz 1989Beecham Laboratories (mupirocin)

Oranje 2007GlaxoSmithKline (retapamulin)

Rist 2002GlaxoSmithKline (mupirocin)

Sutton 1992Leo Laboratories (fusidic acid)

Tack 1997Parke-Davis pharmaceutical research (cefdinir)

Tack 1998Parke-Davis pharmaceutical research (cefdinir)

Wainscott 1985Beecham Pharmaceuticals (mupirocin)

White 1989Beecham Pharmaceuticals (mupirocin)