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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-12
SponsorUniversity Hospital, Rouen

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Infant with acute bronchiolitis

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • biobank

    Other intervention

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

  • follow up

    Other intervention

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

Treatment groups

900 Participants
are divided into 2 treatment groups
Group A: passive immunization2 interventions
Group B: no passive immunization2 interventions

Trial outcomes

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

Time frame
3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.