Measuring how RSV affects young children seen in clinics and hospitals
Official title: Ambulatory Respiratory Tract Infection Survey, Burden of Respiratory Syncitial Virus in the Era of Covid-19
Run by Association Clinique Thérapeutique Infantile du val de Marne · NCT04743609 · Data updated 2026-11-12
This project will test adding lab tests for RSV, flu, and COVID-19 for children under 2 who come to clinics or hospitals with ear infections or bronchiolitis to see how often RSV causes their illness.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Day to 24 Months |
| Sex | All |
| Enrollment | 1900 (estimated) |
| Sponsor | Association Clinique Thérapeutique Infantile du val de Marne Academic / other |
| Locations | 1 site (Créteil) |
| Status | Recruiting |
| Started | February 8, 2021 |
| Main results expected | December 8, 2026 |
| Study ends | December 8, 2026 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT04743609 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 0–24 months with acute purulent otitis media or otorrhea, with or without bronchiolitis, whose parent or guardian provides consent and who are affiliated to a French social security scheme.
✕Probably not a fit
Children older than 24 months, those not affiliated with a social security system, children whose parent/guardian refuses consent, and infants whose mothers received RSV vaccination during the pregnancy are excluded and would not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The protocol adds multiplex laboratory testing (RSV, influenza, SARS-CoV-2) to existing PARI outpatient syndromic surveillance for lower respiratory tract infections using nasopharyngeal samples. All bronchiolitis cases will be followed through the PARI real-world evidence database and the patient journey documented for five years after the first medical visit. Investigators will also review electronic PARI records from three previous seasons to estimate RSV-attributable disease burden in children under 2 in France before enhanced surveillance. Data will combine prospective lab-confirmed cases with retrospective electronic health record analysis to quantify outpatient and hospital impact.
Why it matters
Potential benefit: If successful, this approach could give clinicians and public health teams clearer data on how often RSV causes serious respiratory and ear infections in young children and help guide prevention and resource planning.
How similar studies have gone: Outpatient RSV surveillance and multiplex PCR testing have been used in other settings to produce useful epidemiologic data, but combining that with five-year individual patient journey follow-up in this outpatient network is less commonly done.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Activ
Créteil, France Recruiting
Study contacts
- Study coordinator: Corinne Levy, MD
- Email: corinne.levy@activ-france.fr
- Phone: 0033148850404
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.