Clinical trial Recruiting at 1 site Observational Ages 0 Months to 12 Months

Understanding viral infections in infants with bronchiolitis after Nirsevimab use

Official title: Viral Epidemiology of Bronchiolitis After NIrsevimab Implementation and Respiratory Evolution in Infants

Run by University Hospital, Rouen · NCT06636955 · Data updated 2026-11-12

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 typeObservational
Ages0 Months to 12 Months
SexAll
Enrollment900 (estimated)
SponsorUniversity Hospital, Rouen
Academic / other
Drugs / interventionsNirsevimab
Locations1 site (Rouen)
StatusRecruiting
StartedOctober 7, 2024
Main results expectedOctober 7, 2027
Study endsDecember 31, 2028
Registry record updatedOctober 15, 2024
Trial IDNCT06636955 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients who have had previous episodes of bronchiolitis or those whose parents refuse participation will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Rouen University Hospital
    Rouen, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.