Viral Epidemiology of Bronchiolitis After Nirsevimab Implementation and Respiratory Evolution in Infants
NCT ID: NCT06636955
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
900 participants
OBSERVATIONAL
2024-10-07
2028-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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passive immunization
Patients having received a passive immunization
biobank
* nasopharyngeal swab collection
* nasopharyngeal nasal washes collection, during hospitalization, if any
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
biobank
* nasopharyngeal swab collection
* nasopharyngeal nasal washes collection, during hospitalization, if any
follow up
\- one year follow up: after 1 month, 3 months, 6 months et 12 months
Interventions
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biobank
* nasopharyngeal swab collection
* nasopharyngeal nasal washes collection, during hospitalization, if any
follow up
\- one year follow up: after 1 month, 3 months, 6 months et 12 months
Eligibility Criteria
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Inclusion Criteria
* 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
* Infants parents refused to be called back for follow-up
* No nasopharyngeal swab taken
0 Months
12 Months
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Locations
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Rouen University Hospital
Rouen, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-A01498-39
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024/0184/HP
Identifier Type: -
Identifier Source: org_study_id
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