N/A
N=359
Observational Program to Assess Respiratory Syncytial Virus (RSV) Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis
Respiratory Syncytial Virus (RSV)
Bottom Line
View on ClinicalTrials.gov: NCT02282982 ↗Enrolled (actual)
359
Serious AEs
4.7%
Results posted
Jun 2016
Primary outcome: Primary: Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test — 1 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test |
1 | — |
| PRIMARY Proportion of Infants Who Died From a Confirmed Respiratory Syncytial Virus (RSV) Infection |
— | — |
| SECONDARY Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test |
46 | — |
| SECONDARY Proportion of Participants With Intensive Care Unit (ICU) Admission Among Hospitalized Participants |
1 | — |
| SECONDARY Median Length of Stay (LOS) of Participants in the Intensive Care Unit (ICU) |
35 | — |
| SECONDARY Proportion of Participants Who Received Supplemental Oxygen While Hospitalized |
1 | — |
| SECONDARY Proportion of Participants Who Received Mechanical Ventilation While Hospitalized |
— | — |
| SECONDARY Proportion of Participants With Missed Doses of Palivizumab |
61; 20 | — |
| SECONDARY Proportion of Participants With Co-morbidities During Hospitalizations |
1 | — |
| SECONDARY Median Duration of Mechanical Ventilation Administration During Hospitalizations |
— | — |
| SECONDARY Median Duration of Oxygen Administration During Hospitalizations |
30 | — |
| SECONDARY Proportion of Participants With a Particular Co-morbidity |
148; 45 | — |
Summary
This was a non-interventional, prospective, multi-center study with no control group designed to assess the effectiveness of palivizumab in a population of infants at high-risk of serious Respiratory Syncytial Virus (RSV) illness (infants born ≤ 35 weeks of gestation and infants ≤24 months with Bronchopulmonary Dysplasia (BPD) or Congenital Heart Disease (CHD)). Participants received immunoprophylaxis during the RSV season, defined as October 2014 through April 2015, in routine clinical settings throughout the Russian Federation.
Eligibility Criteria
Inclusion Criteria
- Planned prescription of palivizumab for immunoprophylaxis during RSV season or participants for whom palivizumab was prescribed and who received the first dose of palivizumab no later than 60 days before enrollment in the study
- Infants at high risk of severe RSV infection defined as fulfilling at least one of the following:
- Infants born ≤35 weeks gestational age AND are ≤6 months of age at the onset of the RSV season;
- Infants ≤24 months of age AND with a diagnosis of BPD (defined as oxygen requirement at a corrected gestational age of 36 weeks);
- Infants ≤24 months of age with hemodynamically significant CHD, unoperated or partially corrected.
- Written authorization to use individual data signed by parents or child representative
Exclusion Criteria
- Major congenital malformation aside from CHD
- Chronic pulmonary disease other than BPD
- Acute period of any infection
- Contraindication to palivizumab prescription according to local label
- Administration of a product possibly containing RSV-neutralizing antibody within 30 days prior to enrollment or current administration (includes, but is not restricted to, the following: RSV hyperimmunoglobulin, polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin, varicella zoster hyperimmunoglobulin)
Data sourced from ClinicalTrials.gov (NCT02282982). 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.