NCT06636955 Viral Epidemiology of Bronchiolitis After Nirsevimab Implementation and Respiratory Evolution in Infants
| NCT ID | NCT06636955 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Rouen |
| Condition | Acute Bronchiolitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 900 participants |
| Start Date | 2024-10-07 |
| Primary Completion | 2027-10-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 900 participants in total. It began in 2024-10-07 with a primary completion date of 2027-10-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06636955 clinical trial?
This trial is open to participants of all sexes, aged 0 Months or older, up to 12 Months, studying Acute Bronchiolitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06636955 currently recruiting?
Yes, NCT06636955 is actively recruiting participants. Contact the research team at secretariat.DRC@chu-rouen.fr for enrollment information.
Where is the NCT06636955 trial being conducted?
This trial is being conducted at Rouen, France.
Who is sponsoring the NCT06636955 clinical trial?
NCT06636955 is sponsored by University Hospital, Rouen. The trial plans to enroll 900 participants.