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NCT Number: NCT06636955

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.

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Key information

Conditions

Age range

0 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

    Time frame: 3 years

    Multiplex Polymerase Chain Reaction (nasopharyngeal swab) in the 2 groups

Study contacts

Contact information is provided by the study sponsor or research team.

Cécile Pourcher

CONTACT

[email protected]

0232888990 ext. +33

Hortense PETAT, Doctor

CONTACT

[email protected]

0232888265 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: EBINIR

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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