Viral Epidemiology of Bronchiolitis After Nirsevimab Impl... | NCT06636955

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

NCT06636955

Sponsor

University Hospital, Rouen

Status

Recruiting

Last Update Posted

Oct 15, 2024Actual

Enrollment

900Estimated

Phase

Not provided

Conditions

Acute Bronchiolitis

Interventions

biobank
follow up

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2024-A01498-39	Registry Identifier	ID RCB

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 7, 2024Actual

Primary Completion Date

Oct 7, 2027Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Sep 19, 2024

First Submission Date that Met QC Criteria

Oct 10, 2024

First Posted Date

Oct 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2024

Last Update Posted Date

Oct 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

900Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
passive immunization		Patients having received a passive immunization	Other: biobank Other: follow up
no passive immunization		Patients not having received a passive immunization	Other: biobank Other: follow up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biobank	Other	nasopharyngeal swab collection nasopharyngeal nasal washes collection, during hospitalization, if any	no passive immunization passive immunization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Months

Maximum Age

12 Months

Standard Ages

Child

Study Population

Infant with acute bronchiolitis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hortense PETAT, Doctor	Contact	0232888265	+33	secretariat.DRC@chu-rouen.fr
Cécile Pourcher	Contact	0232888990	+33	secretariat.DRC@chu-rouen.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rouen University Hospital	Recruiting	Rouen		76000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018070	Biological Specimen Banks

Ancestor Terms

ID	Term
D006268	Health Facilities
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided