RSV InfectionOursynNCT04743609
RSV Burden in Outpatient and Hospital Settings
A study testing nasopharyngeal samples in people with RSV Infection and Children, Only, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
Trial summary
Strengthening outpatient low respiratory tract infection surveillance to document the burden of Respiratory Syncytial Virus (RSV) Read more about this study
- Who is it for?
- Ages 1 day to 24 months
- Conditions the study is for
- RSV Infection, Children, Only, Outpatient
- What is being tested?
- nasopharyngeal samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,900 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2021to 8 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
ACTIV
Créteil, 94000
Corinne Levy, MD, 0033148850404, corinne.levy@activ-france.fr
Stéphane Béchet, MSc, 0033148850404, stephane.bechet@activ-france.fr
About this study
Official title: 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)
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
- Conditions
- RSV Infection, Children, Only, Outpatient, Otitis
- Being tested
- nasopharyngeal samples
- Keywords
- RSV, children, otitis with or without concomitant bronchiolitis
- Medical subject headings
- Respiratory Syncytial Virus Infections, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasopharyngeal samplesDiagnostic test
rapid antigen test for Sars Cov-2, influenza and RSV.
| Study group | Role | What they receive |
|---|---|---|
| Otitis associated with bronchiolitis | Experimental | 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. Receives: Diagnostic Test: nasopharyngeal samples |
| otitis without concomitant bronchiolitis | Experimental | 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. Receives: Diagnostic Test: nasopharyngeal samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: day of enrollment
Secondary outcomes (7)
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
Measured: 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.
Measured: 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.
Measured: day of enrollment
Patient care pathway documentation
Number and type of healthcare non-protocol visits, treatments received, and complications
Measured: day of enrollment, at days 15 and at 6 months after inclusion
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.
Measured: 15 days and 6 months after inclusion
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.
Measured: 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
Measured: day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start8 Feb 2021
- Primary completion8 Dec 2026 (estimated)
- Study completion8 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for RSV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A nasopharyngeal specimen will be obtained from the eligible child. The procedure consists of inserting and gently rotating a swab into the posterior nasopharynx to perform a rapid antigen test (nasopharyngeal or nasal). The test provides results within 10 to 15 minutes and determines the presence or absence of respiratory syncytial virus (RSV), influenza viruses, and SARS-CoV-2.
- Masking
- None (open label)
- Enrolment
- 1,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de Marne
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Robert Cohen, Study director, Association Clinique et Thérapeutique Infantile du Val de Marne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743609
- Sponsor's protocol ID
- 2020-A02876-33
- Acronym
- Oursyn
- Status last verified
- Oct 2026
- First submitted
- 20 Jan 2021
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study patients data are stored by ACTIV, but in the event of data transfer to other researchers, they will be fully anonymized.
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 34260480Lenglart 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 39893316Rybak 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 38900603Lenglart 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Respiratory Tract Infection Survey, Burden of Respiratory Syncitial Virus in the Era of Covid-19
- ClinicalTrials.gov ID
- NCT04743609
- Acronym / sponsor ID
- Oursyn / 2020-A02876-33
- Conditions
- RSV Infection, Children, Only, Outpatient, Otitis
- Keywords
- RSV, children, otitis with or without concomitant bronchiolitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,900 participants (estimated)
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de MarneUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 8 Dec 2026 (estimated)
- Study completion
- 8 Dec 2026 (estimated)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Strengthening outpatient low respiratory tract infection surveillance to document the burden of Respiratory Syncytial Virus (RSV)
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A nasopharyngeal specimen will be obtained from the eligible child. The procedure consists of inserting and gently rotating a swab into the posterior nasopharynx to perform a rapid antigen test (nasopharyngeal or nasal). The test provides results within 10 to 15 minutes and determines the presence or absence of respiratory syncytial virus (RSV), influenza viruses, and SARS-CoV-2.
| Arm | Type | Receives |
|---|---|---|
| Otitis associated with bronchiolitis | Experimental | Diagnostic Test: nasopharyngeal samplesOnly 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. |
| otitis without concomitant bronchiolitis | Experimental | Diagnostic Test: nasopharyngeal samplesOnly 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. |
Who may qualify
- Ages
- 1 day to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasopharyngeal samplesrapid antigen test for Sars Cov-2, influenza and RSV. | Diagnostic test | Otitis associated with bronchiolitis, otitis without concomitant bronchiolitis |
Primary outcome
Frequency of otitis media associated or not with bronchiolitis due to RSV in outpatient pediatrics
Time frame: day of enrollment
Number of children presenting with confirmed otitis media, with or without bronchiolitis, attributable to respiratory syncytial virus (RSV)
7 secondary outcomes
Proportion of RSV positive acute otitis media cases with or without associated bronchiolitis in outpatient settings
Time frame: day of enrollment
Impact of Nirsevimab on the burden of otitis media with or without bronchiolitis in outpatients
Time frame: day of enrollment
Proportion of otitis media cases attributable to SARS-CoV-2 in outpatient settings
Time frame: day of enrollment
Patient care pathway documentation
Time frame: day of enrollment, at days 15 and at 6 months after inclusion
Health-Related Quality of Life
Time frame: 15 days and 6 months after inclusion
Socioeconomic impact: Parental work absenteeism
Time frame: 15 days and 6 months after inclusion
Demographic and clinical characteristics of included children
Time frame: day of enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Results publication: PubMed 34260480Rybak 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.
- Results publication: PubMed 39893316Lenglart 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.
- Results publication: PubMed 38900603Rybak 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.
- Results publication: PubMed 41862086Lenglart 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.
- Delayed Bronchiolitis Epidemic in French Primary Care Setting Driven by Respiratory Syncytial Virus: Preliminary Data from the Oursyn Study, March 2021Link provided by the sponsor.
- Nirsevimab effectiveness on paediatric emergency visits for RSV bronchiolitis: a test-negative design studyLink provided by the sponsor.
- 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 StudyLink provided by the sponsor.
- Effectiveness of Nirsevimab on Primary Care Visits for Respiratory Syncytial Virus-Associated Acute Otitis Media in InfantsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Study patients data are stored by ACTIV, but in the event of data transfer to other researchers, they will be fully anonymized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Cohen study director
Association Clinique et Thérapeutique Infantile du Val de Marne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasopharyngeal samples in people with RSV Infection and Children, Only, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corinne Levy, MD (0033148850404, corinne.levy@activ-france.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of otitis media associated or not with bronchiolitis due to RSV in outpatient pediatrics (time frame: day of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04743609, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.