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

NCT06636955 | Recruiting

• 2 other identifiers: 2024/0184/HP2024-A01498-39
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Bronchiolitis

Keywords

Nirsevimab; passive immunization; pediatric emergencies; viral epidemiology; acute bronchilitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

passive immunization

Patients having received a passive immunization

Other: biobank; Other: follow up

no passive immunization

Patients not having received a passive immunization

Other: biobank; Other: follow up

Interventions

biobank OTHER

* nasopharyngeal swab collection * nasopharyngeal nasal washes collection, during hospitalization, if any

no passive immunization; passive immunization

follow up OTHER

\- one year follow up: after 1 month, 3 months, 6 months et 12 months

no passive immunization; passive immunization

Eligibility Criteria

• Age: 0 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infant with acute bronchiolitis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, 76000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

* nasopharyngeal swabs * nasal enema

MeSH Terms

Interventions

Biological Specimen Banks

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services

Central Study Contacts

Hortense PETAT, Doctor

CONTACT

0232888265; secretariat.DRC@chu-rouen.fr

Cécile Pourcher

CONTACT

0232888990; secretariat.DRC@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: October 15, 2024
• Study Start: October 7, 2024
• Primary Completion (Estimated): October 7, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)