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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 1
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Rouen University Hospital
RECRUITING
Rouen
Contact Information
Primary
Hortense PETAT, Doctor
secretariat.DRC@chu-rouen.fr
0232888265
Backup
Cécile Pourcher
secretariat.DRC@chu-rouen.fr
0232888990
Time Frame
Start Date: 2024-10-07
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 900
Treatments
passive immunization
Patients having received a passive immunization
no passive immunization
Patients not having received a passive immunization
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Rouen

This content was sourced from clinicaltrials.gov