N/A
N=464
A One-Year Observation of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America
Respiratory Syncytial Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT01297504 ↗Enrolled (actual)
464
Serious AEs
22.3%
Results posted
Sep 2014
Primary outcome: Primary: Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection — 134; 449; 46; 160 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection |
134; 449; 46; 160; 78; 5 | — |
| PRIMARY Distribution of Comorbidities in Study Participants |
64.63; 0.87; 0.87; 24.45; 5.24; 3.71 | — |
| SECONDARY Number of Participants With Hospitalizations for Lower Respiratory Tract Infection and RSV |
52; 12 | — |
| SECONDARY Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV |
60; 12; 32; 9; 7; 1 | — |
| SECONDARY Risk Factors for Hospitalization |
0.919; 0.925; 0.925; 1.022; 2.768; 2.754 | — |
| SECONDARY Compliance to Prescribed Palivizumab |
83.66 | — |
| SECONDARY Mean Number of Doses of Palivizumab Administered |
3.8 | — |
Summary
The study was designed to gather information regarding the use of palivizumab for the prophylaxis for respiratory syncytial virus (RSV) infection in high-risk infants in selected countries within Latin America.
Eligibility Criteria
Inclusion Criteria
- Children with a history of bronchopulmonary dysplasia, infants with a history of prematurity (less than or equal to 35 weeks gestational age), or children with hemodynamically significant congenital heart disease who received the first dose of palivizumab within the 2 weeks prior to the signature of the Informed Consent Form.
- Parent or legal guardian of child provides written Informed Consent
Exclusion Criteria
- Children excluded from receiving palivizumab as per local guidelines
Data sourced from ClinicalTrials.gov (NCT01297504). 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.