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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 (20 JUL 2016)

[Figure 1]
Figure 1. Sample size of needed randomised controlled trial as a function of power to detect a 50% reduction in rate of hospitalisation due to RSV infection (Type I error=0.05, 1:1 allocation ratio, no dropouts, and using Fisher’s exact test)

Upper Curve - Assuming rate of hospitalisation in control group = 1.06% (Cohen 2005)

Lower Curve - Assuming rate of hospitalisation in control group = 7.5% (Giebels 2008)
[Figure 2]
Figure 2. Sample size of needed randomised controlled trial as a function of power to detect a 50% reduction in rate of hospitalisation due to any respiratory cause (Type I error=0.05, 1:1 allocation ratio, no dropouts, and using Fisher’s exact test)

Upper Curve - Assuming rate of hospitalisation in control group = 14.9% (Cohen 2005)

Lower Curve - Assuming rate of hospitalisation in control group = 17.5% (Giebels 2008)
[Analysis 1.1]
Analysis 1.1. Comparison 1 Palivizumab versus placebo, Outcome 1 Need for hospitalisation for RSV infection.
[Analysis 1.2]
Analysis 1.2. Comparison 1 Palivizumab versus placebo, Outcome 2 Mortality.
[Analysis 1.3]
Analysis 1.3. Comparison 1 Palivizumab versus placebo, Outcome 3 Need for oxygen therapy.
[Analysis 1.4]
Analysis 1.4. Comparison 1 Palivizumab versus placebo, Outcome 4 Adverse events - any.
[Analysis 1.5]
Analysis 1.5. Comparison 1 Palivizumab versus placebo, Outcome 5 Related adverse events.
[Analysis 1.6]
Analysis 1.6. Comparison 1 Palivizumab versus placebo, Outcome 6 Any serious adverse event.
[Analysis 1.7]
Analysis 1.7. Comparison 1 Palivizumab versus placebo, Outcome 7 Related serious adverse event.
[Analysis 1.8]
Analysis 1.8. Comparison 1 Palivizumab versus placebo, Outcome 8 Pseudomonas aeruginosa infections.