NCT06030505

Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,140 (actual)
• Sponsor: Centre Hospitalier Intercommunal Creteil · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

Respiratory tract infections caused by respiratory syncytial virus (RSV) are a worldwide burden and represent a major public health issue. In France, bronchiolitis is responsible for around 100,000 emergency room visits and 50,000 hospital admissions every year; 75% of infants hospitalised for RSV bronchiolitis are healthy full-term children. Recent discoveries concerning the specific viral epitopes of RSV have made it possible to move from an empirical approach to a targeted preventive or curative approach (monoclonal antibodies, vaccines, anti-viral drugs). Nirsevimab is a monoclonal antibody against RSV with enhanced neutralising activity and a prolonged half-life. A randomised, placebo-controlled phase III trial demonstrated the effectiveness of nirsevimab in reducing lower respiratory tract infections caused by RSV requiring medical management in healthy premature and term infants, with a favourable safety profile. The US Food and Drug Administration (FDA) approved the first RSV vaccine on May 3, 2023, and the second was approved on May 31, 2023. Nirsevimab was approved by the European Medicines Agency (EMA) on November 4, 2022.

Conditions

• Bronchiolitis, Viral

Interventions

Type	Name	Description
OTHER	No intervention required by the protocol	No visits or samples will be taken specifically for this study. This research involves only prospective or retrospective data collection in relation to the usual hospital management of the child included. Similarly, patient follow-up will be strictly within the framework of their usual hospital care in relation to their pathology.

Timeline

• Start date: 2023-10-15
• Primary completion: 2023-12-29
• Completion: 2023-12-29
• First posted: 2023-09-11
• Last updated: 2025-08-29

Locations

5 sites across 1 country: France