Understanding viral infections in infants with bronchiolitis after Nirsevimab use
Viral Epidemiology of Bronchiolitis After NIrsevimab Implementation and Respiratory Evolution in Infants
This study looks at how the use of Nirsevimab affects the types of viral infections in infants under one year old who have their first episode of bronchiolitis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 0 Months to 12 Months |
| Sex | All |
| Sponsor | University Hospital, Rouen Academic / other |
| Drugs / interventions | Nirsevimab |
| Locations | 1 site (Rouen) |
| Trial ID | NCT06636955 on ClinicalTrials.gov |
What this trial studies
This observational study aims to monitor the viral epidemiology of acute bronchiolitis in infants under 12 months after the implementation of Nirsevimab, a long-acting antibody against RSV. It will include infants presenting with their first episode of bronchiolitis at the pediatric emergency department over three epidemic seasons. Clinical data will be collected alongside nasopharyngeal swabs, which will undergo multiplex Polymerase Chain Reaction to identify the responsible respiratory viruses. The study seeks to understand how Nirsevimab affects the prevalence of various respiratory viruses in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are infants aged 12 months or younger who are experiencing their first episode of acute bronchiolitis and are admitted to the pediatric emergency department.
Not a fit: Patients who have had previous episodes of bronchiolitis or those whose parents refuse participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of Nirsevimab in altering the landscape of respiratory infections in infants, potentially leading to improved management strategies.
How similar studies have performed: While the approach of monitoring viral epidemiology in the context of Nirsevimab is relatively novel, similar studies have shown promise in understanding respiratory infections in pediatric populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infant aged 12 months or less * Admitted to the pediatric emergencies services during one of the three epidemic years: 2024-2025, 2025-2026 and 2026-2027 * With clinical diagnosis of first episode of acute bronchiolitis by the emergency pediatrician * With nasopharyngeal swab for virological diagnosis Exclusion Criteria: * Refusal of one or more of the infants parents to participate in the study * Infants parents refused to be called back for follow-up * No nasopharyngeal swab taken
Where this trial is running
Rouen
- Rouen University Hospital — Rouen, France (Recruiting)
Study contacts
- Study coordinator: Hortense PETAT, Doctor
- Email: secretariat.DRC@chu-rouen.fr
- Phone: 0232888265
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.