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 type | Observational |
|---|---|
| Ages | 0 Months to 12 Months |
| Sex | All |
| Enrollment | 900 (estimated) |
| Sponsor | University Hospital, Rouen Academic / other |
| Drugs / interventions | Nirsevimab |
| Locations | 1 site (Rouen) |
| Status | Recruiting |
| Started | October 7, 2024 |
| Main results expected | October 7, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | October 15, 2024 |
| Trial ID | NCT06636955 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
- Study coordinator: Hortense PETAT, Doctor
- Email: secretariat.DRC@chu-rouen.fr
- Phone: 0232888265
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Montelukast for acute bronchiolitis in infants and young children
This study tests whether adding montelukast to standard care helps shorten hospital stays and relieve symptoms in indoor patients aged 4 weeks to 2 years with acute bronchiolitis.
-
Shortening antibiotic courses for common throat and chest infections in primary care with doctor–pharmacist teamwork and viral‑circulation updates
This project will test whether giving primary care doctors and pharmacists extra information about circulating viruses plus a shared protocol helps shorten antibiotic courses for patients with common respiratory infections.
-
Preventing RSV in Babies: Nirsevimab with or without maternal RSV vaccine
This study tests whether giving a monoclonal antibody to newborns, with or without the mother’s vaccination during pregnancy, can better protect infants from RSV than giving just one option.
-
Evaluating Nirsevimab's effect on RSV hospitalizations in infants
This study is testing if a new antibody called Nirsevimab can help prevent infants under one year old from being hospitalized due to RSV infections.
-
Comparing two methods for stopping high flow nasal cannula treatment in infants with acute bronchiolitis
This study is testing whether stopping high flow nasal cannula treatment right away or gradually is better for helping infants with acute bronchiolitis leave the hospital sooner and safely.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.