N/A
N=2,569
Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease
Severe Respiratory Syncytial Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT01075178 ↗Enrolled (actual)
2,569
Serious AEs
32.3%
Results posted
Feb 2011
Primary outcome: Primary: Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection, Serious Arrhythmia and/or Death — 303; 349 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection, Serious Arrhythmia and/or Death |
303; 349 | — |
| PRIMARY Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection. |
281; 329 | — |
| PRIMARY Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Arrhythmia |
41; 39 | — |
| PRIMARY Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Death |
9; 10 | — |
Summary
Retrospective medical record review study of specific adverse events in children with congenital heart disease who received palivizumab for prophylaxis of serious respiratory syncytial virus infection and control subjects that did not receive palivizumab
Eligibility Criteria
Inclusion Criteria
- Subject must have documented hemodynamically significant congenital heart disease (Note: Children with uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus are not eligible).
- Subject must have unoperated or partially corrected congenital heart disease.
- Subject must have received at least one dose of palivizumab for prophylaxis during the Respiratory Syncytial Virus season - September 1 through April 30 (CASES), or would have been considered eligible for palivizumab prophylaxis (CONTROLS).
- Subject must be < 24 months of age at the time of the first dose of palivizumab prophylaxis (CASES) or < 32 months of age at the end of the assigned Respiratory Syncytial Virus season in which they would have been eligible to receive palivizumab if the drug had been approved in the European Union (CONTROLS).
- Subject's parent, guardian, or legal representative has voluntarily signed and dated a Release of Information Form to allow the review of medical records and collection of pertinent study data.
Exclusion Criteria
- Subject was contraindicated for treatment with palivizumab according to the current European product label.
- Subject had full correction of Congenital Heart Disease.
- Subject received palivizumab before approval for use in Congenital Heart Disease (CASES), or subject received palivizumab at any time (CONTROLS).
- Subject has already been included in this study in a prior Respiratory Syncytial Virus season.
Data sourced from ClinicalTrials.gov (NCT01075178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.