N/A
Completed N=30,804
Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany
Source: ClinicalTrials.gov NCT01155193 ↗Enrolled (actual)
30,804
Serious AEs
2.4%
Results posted
Oct 2018
Primary outcomePrimary: Percentage of Participants With RSV-associated Hospitalization — 1.5; 1.5; 0.8; 0.7 percentage of participants
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.
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 | — |
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. Informational only — not medical advice.