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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Bronchiolitis
• Intervention / Treatment: Other: biobank; Other: follow up

• Study Type: Observational
• Enrollment (Estimated): 900

Contacts and Locations

• Study Contact: Name: Hortense PETAT, Doctor; Phone Number: +33 0232888265; Email: secretariat.DRC@chu-rouen.fr
• Study Contact Backup: Name: Cécile Pourcher; Phone Number: +33 0232888990; Email: secretariat.DRC@chu-rouen.fr

Study Locations

• France
  • Rouen, France, 76000
    • Recruiting
    • Rouen University Hospital
    • Contact: David Mallet; Phone Number: +33 02 32 88 82 65; Email: secretariat.DRC@chu-rouen.frv

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Infant with acute bronchiolitis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
passive immunization; Patients having received a passive immunization	Other: biobank; nasopharyngeal swab collection; nasopharyngeal nasal washes collection, during hospitalization, if any; Other: follow up; - one year follow up: after 1 month, 3 months, 6 months et 12 months
no passive immunization; Patients not having received a passive immunization	Other: biobank; nasopharyngeal swab collection; nasopharyngeal nasal washes collection, during hospitalization, if any; Other: follow up; - one year follow up: after 1 month, 3 months, 6 months et 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Multiplex Polymerase Chain Reaction (nasopharyngeal swab) in the 2 groups	3 years

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2024
• Primary Completion (Estimated): October 7, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Nirsevimab; passive immunization; pediatric emergencies; viral epidemiology; acute bronchilitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: 2024/0184/HP; 2024-A01498-39 (Registry Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No