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

NCT06636955 — Recruiting, 900 participants, University Hospital, Rouen

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

RegistryNCT06636955, acronym EBINIR
StatusRecruiting
Study typeObservational
Enrollment900 (Estimated)
SponsorUniversity Hospital, Rouen (Other)
ConditionsAcute Bronchiolitis
Interventionsbiobank, follow up (Other)
Datesstart 2024-10-07, primary completion 2027-10-07 (estimated), completion 2028-12-31 (estimated), first posted 2024-10-15, last updated 2024-10-15
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Acute Bronchiolitis All trials of biobank All trials of follow up

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
passive immunizationOther: biobank; Other: follow upPatients having received a passive immunization
no passive immunizationOther: biobank; Other: follow upPatients not having received a passive immunization
  • biobank (Other): * nasopharyngeal swab collection * nasopharyngeal nasal washes collection, during hospitalization, if any
  • follow up (Other): \- one year follow up: after 1 month, 3 months, 6 months et 12 months

+Outcome measures

Primary outcomes

  • 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 [3 years]: Multiplex Polymerase Chain Reaction (nasopharyngeal swab) in the 2 groups

+Eligibility

Sex: All, ages: 0 Months to 12 Months

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

+Locations (1)

FacilityCityCountryStatus
Rouen University HospitalRouenFranceRecruiting