Viral Epidemiology of Bronchiolitis After Nirsevimab Implementation and Respiratory Evolution in Infants

Recruiting

• Conditions: Acute Bronchiolitis

• Registration Number: NCT06636955
• Lead Sponsor: University Hospital, Rouen

Brief Summary

Acute bronchiolitis in infants, mainly caused by the Respiratory Syncytial Virus (RSV), is a public health issue, in terms of morbidity and hospital costs.

Nirsevimab, a long-acting antibody against RSV available for all infants under 12 months, could profoundly modify the epidemiology of the next epidemic seasons, with the increase of the frequency of the other respiratory viruses (endemic Coronaviruses, Metapneumovirus, etc) Monitoring viral ecology is important, as the impact of respiratory infections on morbidity in the short, medium and long term, but also in economic terms.

Infants under the age 12 months with a first episode of bronchiolitis and consulting the emergency pediatric department will be included. A nasopharyngeal swab will be performed as routine care, and clinical data will be collected.

Multiplex Polymerase Chain Reaction will be performed to identify respiratory virus(es) responsible for the bronchiolitis. In hospitalized infants with RSV or rhinovirus positive Polymerase Chain Reaction (PCR), daily nasal washes will be collected to perform viral loads with specific quantitative PCR (nasal washes biobank), associated with daily clinical data. A 12-month follow-up is planned for every infant included, consisting with 4 phone calls, to identify factors associated with the onset of preschool wheezing.

The main objective is to describe the viral epidemiology associated with acute bronchiolitis leading to a pediatric emergency department visit the implementation of Nirsevimab.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-19
• Status Verified: 2024-10
• Study Start: 2024-10-07
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Study First Posted: 2024-10-11
• Last Update Posted: 2024-10-11
• Primary Completion: 2027-10-07
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be the prevalence of viral populations identified by respiratory multiplex PCR ( nasopharyngeal swab) in the group with Nirsevimab and in the group without Nirsevimab	3 years	Multiplex Polymerase Chain Reaction (nasopharyngeal swab) in the 2 groups

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France