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Intervention Review

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Palivizumab for prophylaxis against respiratory syncytial virus infection in children with cystic fibrosis

  1. Karen A Robinson1,*,
  2. Olaide A Odelola2,
  3. Ian J Saldanha3,
  4. Naomi A Mckoy4

Editorial Group: Cochrane Cystic Fibrosis and Genetic Disorders Group

Published Online: 5 JUN 2013

Assessed as up-to-date: 17 APR 2013

DOI: 10.1002/14651858.CD007743.pub4


How to Cite

Robinson KA, Odelola OA, Saldanha IJ, Mckoy NA. Palivizumab for prophylaxis against respiratory syncytial virus infection in children with cystic fibrosis. Cochrane Database of Systematic Reviews 2013, Issue 6. Art. No.: CD007743. DOI: 10.1002/14651858.CD007743.pub4.

Author Information

  1. 1

    Johns Hopkins University, Department of Medicine, Baltimore, MD, USA

  2. 2

    Albert Einstein Medical Center, Department of Internal Medicine, Philedelphia, PA, USA

  3. 3

    Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology, Baltimore, MD, USA

  4. 4

    Human Genome Sciences, Inc., SSM Microbial Upstream Common Use Production, Rockville, Maryland, USA

*Karen A Robinson, Department of Medicine, Johns Hopkins University, 1830 E. Monument St., Suite 8068, Baltimore, MD, 21287, USA. krobin@jhmi.edu.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 5 JUN 2013

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This is not the most recent version of the article. View current version (22 MAY 2014)

 
Characteristics of included studies [author-defined order]
Cohen 2005

MethodsMulti-centre double-blind placebo-controlled trial in the USA. Parallel design. 40 centres.


Participants186 participants, all analysed. Mean (range) age = 12.8 (0.4 to 24.4) months.


InterventionsPlacebo versus palivizumab.


OutcomesAt 6 months follow up - number of patients hospitalised for RSV infection, mortality, adverse events.

At 12 months follow up - nutritional status (weight/height ratio), number of infections with Pseudomonas aeruginosa.


Intention-to-treat analysisYes.


NotesOf 186 participants, 5 were lost to follow-up. All who received at least one dose were analysed (n = 186). Data abstracted from poster and from additional results provided by the investigators.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskClarification sought from authors, but not obtained.

Allocation concealment (selection bias)Low riskAssignment of participants to groups was done by a pharmacy.

Blinding (performance bias and detection bias)
All outcomes
Low riskDouble blinded, including participants, investigators, outcome assessors, data analysts, and sponsors.

Incomplete outcome data (attrition bias)
All outcomes
Low riskFive participants (2.7%) were lost to follow up.

Selective reporting (reporting bias)Unclear riskMethods mention weight gain, change in pulmonary medications, incidence of Pseudomonas colonization, incidence of documented wheezing episodes, and duration of steroid usage assessed at 12 months follow-up. Results state that there were no significant differences in outcomes at that time point, but no data provided. When we contacted the authors of the trial, we received information on weight gain and incidence of  Pseudomonas colonization.

Other biasUnclear riskClarification sought from authors, not obtained.

 
Comparison 1. Palivizumab versus placebo

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Need for hospitalisation for RSV infection1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Up to 6 months
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Mortality1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 Up to 6 months
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Need for oxygen therapy1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    3.1 Up to 6 months
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 4 Adverse events - any1Odds Ratio (M-H, Fixed, 95% CI)Totals not selected

    4.1 Up to 6 months
1Odds Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 5 Related adverse events1Odds Ratio (M-H, Fixed, 95% CI)Totals not selected

    5.1 Up to 6 months
1Odds Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 6 Any serious adverse event1Odds Ratio (M-H, Fixed, 95% CI)Totals not selected

    6.1 Up to 6 months
1Odds Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 7 Related serious adverse event1Odds Ratio (M-H, Fixed, 95% CI)Totals not selected

    7.1 Up to 6 months
1Odds Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 8 Pseudomonas aeruginosa infections1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    8.1 Up to 6 months
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]