Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636955
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Viral Epidemiology of Bronchiolitis After Nirsevimab Implementation and Respiratory Evolution in Infants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Viral Epidemiology of Bronchiolitis After NIrsevimab Implementation and Respiratory Evolution in Infants
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EBINIR
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 viruses 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
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 viruses 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None