drugset / Trial / NCT02442427

"Palivizumab Therapy for RSV-bronchiolitis"

NCT02442427

Phase 3 Completed 420 enrolled Hamad Medical Corporation
RandomizedParallel-groupQuadruple-blindTreatment

Summary

There is a growing body of literature suggesting that monoclonal antibody could be efficacious in infants with RSV-bronchiolitis, well tolerated with no or clinically insignificant adverse effects. "The investigators hypothesize that a single dose of iv palivizumab 15 mg/kg in diagnosed infants \<3 months old with RSV bronchiolitis will result in fewer infants with readmissions to infirmary/observation or hospital for relapse during 3 weeks of follow-up after discharge".

Timeline

Start
2014-09
Primary completion
2018-02-01
Completion
2018-02-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Palivizumab Monoclonal antibody 15 mg/kg Intravenous