N/A
N=30,804
Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany
Respiratory Syncytial Virus Infections
Bottom Line
View on ClinicalTrials.gov: NCT01155193 ↗Enrolled (actual)
30,804
Serious AEs
2.4%
Results posted
Oct 2018
Primary outcome: Primary: Percentage of Participants With RSV-associated Hospitalization — 1.5; 1.5; 0.8; 0.7 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With RSV-associated Hospitalization |
1.5; 1.5; 0.8; 0.7 | — |
| SECONDARY Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08 |
67; 18; 99; 34; 26; 12 | — |
| SECONDARY Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 |
24; 24; 115; 4; 32; 15 | — |
| SECONDARY Presence of Complications During Hospitalization |
111; 29; 22; 14; 56; 177 | — |
| SECONDARY Parental Cooperation in Registries 02/03 - 06/07 and 07/08 |
9383; 3340; 567; 221; 354; 102 | — |
| SECONDARY Parental Cooperation for Registry 08/09 and 09/10 - 15/16 |
8175; 51408; 550; 2985; 143; 575 | — |
| SECONDARY Mean Number of Palivizumab Injections |
4.7; 4.8; 4.9; 5.0 | — |
Summary
The SYNAGIS Registry was carried out in order to gather comprehensive real-world data on the use of palivizumab in children at high risk for serious respiratory syncytial virus (RSV) disease. This registry was designed as a post-marketing observational study, and conducted with the aim of collecting data on palivizumab administration, the risk factors for complicated RSV disease, frequency of hospitalizations, and drug adherence.
Eligibility Criteria
Inclusion Criteria
- Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the Respiratory syncytial virus season
- Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months.
- Children less than 2 years of age and with hemodynamically significant congenital heart disease.
Exclusion Criteria
- Children with known hypersensitivity to palivizumab or any component of the formulation, or other humanized monoclonal antibodies
Data sourced from ClinicalTrials.gov (NCT01155193). 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.