RSV Burden in Outpatient and Hospital Settings (Oursyn)

Ambulatory Respiratory Tract Infection Survey, Burden of Respiratory Syncitial Virus in the Era of Covid-19

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

Study Overview

• Status: Recruiting
• Conditions: Otitis; Children, Only; RSV Infection; Outpatient
• Intervention / Treatment: Diagnostic test: nasopharyngeal samples

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

• Study Type: Interventional
• Enrollment (Estimated): 1900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Corinne Levy, MD; Phone Number: 0033148850404; Email: corinne.levy@activ-france.fr
• Study Contact Backup: Name: Stéphane Béchet, MSc; Phone Number: 0033148850404; Email: stephane.bechet@activ-france.fr

Study Locations

• France
  • Créteil, France, 94000
    • Recruiting
    • ACTIV
    • Contact: Corinne Levy, MD; Phone Number: 0033148850404; Email: corinne.levy@activ-france.fr
    • Contact: Stéphane Béchet, MSc; Phone Number: 0033148850404; Email: stephane.bechet@activ-france.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 years (Child)
• Accepts Healthy Volunteers: No

Study Population

children under 24 months old with first episode of bronchiolitis or acute otitis media or pneumonia

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; rapid antigen test for Sars Cov-2, influenza and RSV.
Experimental: Otitis not associated with Bronchiolitis; Only for city physicians: A total of 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; rapid antigen test for Sars Cov-2, influenza and RSV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	day of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	day of enrollment
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.	day of enrollment
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.	day of enrollment
Patient care pathway documentation	Number and type of healthcare non-protocol visits, treatments received, and complications	day of enrollment, at days 15 and at 6 months after inclusion
Score of Quality of life	Health-related quality of life assessed using the PedsQL test, according to RSV status and nirsevimab immunization status.	15 days and 6 months after inclusion
Socioeconomic impact: Parental work absenteeism	Number of days parents miss work due to the child's illness, according to children RSV status and nirsevimab immunization	15 days and 6 months after inclusion
Demographic and clinical characteristics of included children	Analysis of characteristics such as prematurity, comorbidities, and Nirsevimab immunization status	day of enrollment

Collaborators and Investigators

• Sponsor: Association Clinique Thérapeutique Infantile du val de Marne
• Collaborators: Sanofi
• Investigators: Study Director: Robert Cohen, Association Clinique et Thérapeutique Infantile du Val de Marne

Publications and helpful links

General 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.
• 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.
• 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.

Helpful Links

• Delayed Bronchiolitis Epidemic in French Primary Care Setting Driven by Respiratory Syncytial Virus: Preliminary Data from the Oursyn Study, March 2021
• Nirsevimab effectiveness on paediatric emergency visits for RSV bronchiolitis: a test-negative design study
• 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

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2021
• Primary Completion (Estimated): December 8, 2026
• Study Completion (Estimated): December 8, 2026

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: children; RSV; otitis with or without concomitant bronchiolitis
• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Otorhinolaryngologic Diseases; Ear Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Respiratory Syncytial Virus Infections; Otitis
• Other Study ID Numbers: 2020-A02876-33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study patients data are stored by ACTIV, but in the event of data transfer to other researchers, they will be fully anonymized.
• IPD Sharing Time Frame: Data will become available 12 months after publication of the primary results and will be accessible for 5 years
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No