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RecruitingNCT04743609OursynUpdated Oct 29, 2026

RSV Burden in Outpatient and Hospital Settings

An interventional study of nasopharyngeal samples in RSV Infection, Children, Only and Outpatient, sponsored by Association Clinique Thérapeutique Infantile du val de Marne. Recruiting at 1 site in France. Open to participants aged 1 Day to 24 Months. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Association Clinique Thérapeutique Infantile du val de Marne · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Feb 2021; still recruiting 5 years 9 months later.
Updated Oct 29, 2026Interventions changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
1,900
Allocation
Non-randomized
Ages
1 Day to 24 Months
Sex
All
01

Study summary

Strengthening outpatient low respiratory tract infection surveillance to document the burden of Respiratory Syncytial Virus (RSV)

Read the detailed description

The study protocol is designed with three key components: 1. Build on existing PARI outpatient syndromic surveillance by adding laboratory multiplex testing of LRTI samples (RSV, Influenza, SARS-COV-2) 2. Follow all bronchiolitis through the PARI RWE database and document "patient journey" for 5 years after first medical visit 3. Review the electronic PARI data of three previous seasons in order to document the impact of LRTI attributable to RSV in children \< 2 years in France prior to enhanced surveillance

02

Conditions studied

  • RSV Infection
  • Children, Only
  • Outpatient
  • Otitis

Keywords

  • RSV
  • children
  • otitis with or without concomitant bronchiolitis
03

In context

Respiratory Syncytial Virus Infections

306 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 50 are open to participants now.

This study's planned enrollment of 1,900 is above the median of 89 across 223 interventional studies indexed under Respiratory Syncytial Virus Infections.

Browse Respiratory Syncytial Virus Infections studies →

Lead sponsor

Association Clinique Thérapeutique Infantile du val de Marne is the lead sponsor of 15 studies on the registry; 11 are open to participants now.

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

04

Who can participate

Ages eligible
1 Day to 24 Months
Sexes eligible
All
Accepts healthy volunteers
No

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

  • children under 24 months of age (≤)
  • One of the holders of parental authority signed the consent
  • Patient affiliated to a social security scheme (Social Security or Universal Medical Coverage)
  • Acute purulent otitis media (Paradise Criteria) or otorrhea with or withitout associated bronchiolitis

Exclusion criteria

Exclusion Criteria:

  • Age >24 months
  • Refusal by one of the parents
  • Not affiliated to a social security system
  • Maternal RSV vaccination during the pregnancy of the included child
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,900 participants (estimated)

Study arms

  • Experimental
    Otitis associated with bronchiolitis

    Only for city physicians: 800 children presenting with acute otitis media associated with bronchiolitis will undergo a rapid antigen diagnostic test for respiratory syncytial virus (RSV), influenza viruses, and SARS-CoV-2, using a nasopharyngeal swab.

    Diagnostic Test: nasopharyngeal samples

  • Experimental
    otitis without concomitant bronchiolitis

    Only for city physicians: 1,100 children presenting with acute otitis media, without concomitant bronchiolitis, will undergo a rapid antigen diagnostic test for respiratory syncytial virus (RSV), influenza viruses, and SARS-CoV-2, using a nasopharyngeal swab.

    Diagnostic Test: nasopharyngeal samples

Interventions

  • Diagnostic testnasopharyngeal samples

    rapid antigen test for Sars Cov-2, influenza and RSV.

06

What researchers measure

Primary outcomes

  1. Frequency of otitis media associated or not with bronchiolitis due to RSV in outpatient pediatrics

    Number of children presenting with confirmed otitis media, with or without bronchiolitis, attributable to respiratory syncytial virus (RSV)

    Time frame: day of enrollment

Secondary outcomes

  1. Proportion of RSV positive acute otitis media cases with or without associated bronchiolitis in outpatient settings

    Percentage of children with acute otitis media (OMA) testing positive for RSV, with or without concomitant bronchiolitis

    Time frame: day of enrollment

  2. Impact of Nirsevimab on the burden of otitis media with or without bronchiolitis in outpatients

    Assessment of the effect of nirsevimab prophylaxis on the frequency and severity of otitis media, with or without bronchiolitis.

    Time frame: day of enrollment

  3. Proportion of otitis media cases attributable to SARS-CoV-2 in outpatient settings

    Percentage of otitis media cases associated or not with bronchiolitis caused by SARS-CoV-2.

    Time frame: day of enrollment

  4. Patient care pathway documentation

    Number and type of healthcare non-protocol visits, treatments received, and complications

    Time frame: day of enrollment, at days 15 and at 6 months after inclusion

  5. Health-Related Quality of Life

    Health-related quality of life assessed using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales, according to RSV status and nirsevimab immunization status. The PedsQL total score ranges from 0 to 100, where higher scores indicate a better health-related quality of life outcome.

    Time frame: 15 days and 6 months after inclusion

  6. Socioeconomic impact: Parental work absenteeism

    Total number of missed workdays by parents or legal guardians due to the child's illness, assessed according to RSV status and nirsevimab immunization status. The score represents the cumulative number of days absent (minimum value: 0 days, no maximum pre-specified value), where higher values indicate a worse socioeconomic outcome.

    Time frame: 15 days and 6 months after inclusion

  7. Demographic and clinical characteristics of included children

    Analysis of characteristics such as prematurity, comorbidities, and Nirsevimab immunization status

    Time frame: day of enrollment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Rybak A, Levy C, Jung C, Bechet S, Batard C, Hassid F, Zouari M, Cahn-Sellem F, Bangert M, Cohen R. Delayed Bronchiolitis Epidemic in French Primary Care Setting Driven by Respiratory Syncytial Virus: Preliminary Data from the Oursyn Study, March 2021. Pediatr Infect Dis J. 2021 Dec 1;40(12):e511-e514. doi: 10.1097/INF.0000000000003270. PubMed 34260480 ↗
  • Lenglart L, Levy C, Basmaci R, Levieux K, Kramer R, Mari K, Bechet S, Launay E, Cohen L, Aupiais C, de Pontual L, Rybak A, Lassoued Y, Ouldali N, Cohen R. Nirsevimab effectiveness on paediatric emergency visits for RSV bronchiolitis: a test-negative design study. Eur J Pediatr. 2025 Feb 1;184(2):171. doi: 10.1007/s00431-025-06008-9. PubMed 39893316 ↗
  • Rybak A, Cohen R, Bangert M, Kramer R, Delobbe JF, Deberdt P, Cahn-Sellem F, Bechet S, Levy C. Assessing the Burden of Respiratory Syncytial Virus-related Bronchiolitis in Primary Care and at 15-Day and 6-Month Follow-up Before Prophylaxis in France: A Test-negative Study. Pediatr Infect Dis J. 2024 Jul 1;43(7):657-662. doi: 10.1097/INF.0000000000004360. Epub 2024 Apr 10. PubMed 38900603 ↗
  • Lenglart L, Levy C, Batard C, Delobbe JF, Lecailler F, Bechet S, Fafi I, Boulhol M, Kramer R, Rybak A, Ouldali N, Cohen R. Effectiveness of Nirsevimab on Primary Care Visits for Respiratory Syncytial Virus-Associated Acute Otitis Media in Infants. J Pediatr. 2026 Jul;294:115067. doi: 10.1016/j.jpeds.2026.115067. Epub 2026 Mar 19. PubMed 41862086 ↗

Individual participant data

Plan to share: Yes — Study patients data are stored by ACTIV, but in the event of data transfer to other researchers, they will be fully anonymized.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code

Time frame: Data will become available 12 months after publication of the primary results and will be accessible for 5 years

Access criteria: Access will be granted to qualified researchers after submission of a research proposal and approval by ACTIV. All shared data will be fully anonymized to protect participant confidentiality. Use of the data is restricted to scientific research purposes only

09

Updates

1 registry update since Sep 25, 2026
Interventions
Arm changed Otitis not associated with Bronchiolitis→otitis without concomitant bronchiolitis
Oct 29, 2026
Secondary outcomes
1 edited, 1 description edited
What changed in the outcomes
  • EditedScore ofHealth-Related Quality of lifeLifeTime frame: 15 days and 6 months after inclusion
  • DescriptionSocioeconomic impact: Parental work absenteeism: how it is measured was reworded
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Secondary outcomes 1 edited, 1 description edited
    What changed in the outcomes
    • EditedScore ofHealth-Related Quality of lifeLifeTime frame: 15 days and 6 months after inclusion
    • DescriptionSocioeconomic impact: Parental work absenteeism: how it is measured was reworded
    Interventions Arm changed Otitis not associated with Bronchiolitis→otitis without concomitant bronchiolitis
    + 3 other changes: verification date, design details and references

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04743609
Lead sponsor
Association Clinique Thérapeutique Infantile du val de Marne
Collaborators
Sanofi
Responsible party
Sponsor
First posted
Feb 8, 2021
Start date
Feb 8, 2021
Primary completion
Dec 8, 2026 (estimated)
Completion
Dec 8, 2026 (estimated)
Last update
Oct 29, 2026

Study contacts

Corinne Levy, MD
Contact
corinne.levy@activ-france.fr
0033148850404
Stéphane Béchet, MsC
Contact
stephane.bechet@activ-france.fr
0033148850404
Robert Cohen
study director · Association Clinique et Thérapeutique Infantile du Val de Marne

Oversight

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

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