Evaluating Nirsevimab for Children with RSV Bronchiolitis
Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis
This study is testing if a new treatment called nirsevimab can help babies under 12 months who are in the hospital with RSV bronchiolitis feel better compared to those hospitalized for other reasons.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 963 (estimated) |
| Ages | N/A to 1 Year |
| Sex | All |
| Sponsor | Centre Hospitalier Intercommunal Creteil Academic / other |
| Drugs / interventions | Palivizumab, Nirsevimab |
| Locations | 5 sites (Bondy and 4 other locations) |
| Trial ID | NCT06030505 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of nirsevimab, a monoclonal antibody, in children under 12 months who are hospitalized with acute RSV bronchiolitis. The study will compare hospitalized children with RSV bronchiolitis to those hospitalized for other non-respiratory conditions. By leveraging recent advancements in understanding RSV, the study seeks to provide insights into targeted preventive treatments for this common viral infection. The findings could help refine treatment protocols and improve patient outcomes in pediatric care.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 12 months of age who are hospitalized due to acute RSV bronchiolitis.
Not a fit: Patients who are older than 12 months or those hospitalized for conditions unrelated to respiratory symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for infants hospitalized with RSV bronchiolitis, potentially reducing hospital admissions and associated healthcare costs.
How similar studies have performed: Previous studies have shown success with monoclonal antibodies like nirsevimab in reducing RSV-related hospitalizations, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Cases : * Children under 12 months of age * Treated for acute RSV bronchiolitis * Hospitalised following a visit to the paediatric emergency department Controls : * Children under 12 months * Hospitalised in the conventional sector or in a short-stay hospital unit, or having consulted a paediatric emergency department for one of the following reasons * Febrile urinary tract infection, without acute ear, nose, and throat (ENT) or respiratory symptoms * Acute gastroenteritis, without acute ENT or respiratory symptoms * Infant colic without fever, without ENT or acute respiratory symptoms * Stagnant weight or feeding difficulties without fever, acute ENT or respiratory symptoms * Neonatal jaundice without fever or acute ENT or respiratory symptoms * Unexplained crying without fever, without ENT or acute respiratory symptoms * Head injury, without acute ENT or respiratory symptoms * Patient hospitalised for acute surgery without fever, without ENT or acute respiratory symptoms Exclusion Criteria: * Refusal to participate by the patient, their relative or legal representative * Administration of Palivizumab. * Maternal vaccination against RSV.
Where this trial is running
Bondy and 4 other locations
- CHU Bondy - Jean Verdier — Bondy, France (Recruiting)
- CHI Créteil — Créteil, France (Recruiting)
- Hôpital Armand Trousseau AP-HP — Paris, France (Recruiting)
- CHU Robert-Debré — Paris, France (Recruiting)
- CHU Toulouse-hôpital des Enfants — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: Camille JUNG
- Email: camille.jung@chicreteil.fr
- Phone: 0145175000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.