ClinicalTrials.gg
RecruitingNCT06636955EBINIRUpdated Oct 15, 2024

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

An observational study in Acute Bronchiolitis, sponsored by University Hospital, Rouen. Recruiting at 1 site in France. Open to participants aged 0 Months to 12 Months. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by University Hospital, Rouen · Observational

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
900
Ages
0 Months to 12 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Bronchiolitis

Browse trials for

Keywords

  • Nirsevimab
  • passive immunization
  • pediatric emergencies
  • viral epidemiology
  • acute bronchilitis
03

In context

Bronchiolitis

289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.

This study's planned enrollment of 900 is above the median of 200 across 79 observational studies indexed under Bronchiolitis.

Browse Bronchiolitis studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 418 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Months to 12 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Infant with acute bronchiolitis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
900 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Otherbiobank

    * nasopharyngeal swab collection * nasopharyngeal nasal washes collection, during hospitalization, if any

  • Otherfollow up

    - one year follow up: after 1 month, 3 months, 6 months et 12 months

06

What researchers measure

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

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

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2024 (actual). Primary completion is estimated for Oct 2027, 36 months after the start.

Of 26 observational studies under Bronchiolitis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 87. This study's planned 36 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2024
First posted
Oct 15, 2024
StartActual
Oct 7, 2024
Primary completionEst.
Oct 7, 2027
CompletionEst.
Dec 31, 2028
Last update
Oct 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06636955
Responsible party
Sponsor
First posted
Oct 15, 2024
Start date
Oct 7, 2024
Primary completion
Oct 7, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Oct 15, 2024

Study contacts

Hortense PETAT, Doctor
Contact
secretariat.DRC@chu-rouen.fr
0232888265 ext. +33
Cécile Pourcher
Contact
secretariat.DRC@chu-rouen.fr
0232888990 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion