Measuring how RSV affects young children seen in clinics and hospitals
Ambulatory Respiratory Tract Infection Survey, Burden of Respiratory Syncitial Virus in the Era of Covid-19
NA · Association Clinique Thérapeutique Infantile du val de Marne · NCT04743609
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1900 (estimated) |
| Ages | 1 Day to 24 Months |
| Sex | All |
| Sponsor | Association Clinique Thérapeutique Infantile du val de Marne (other) |
| Locations | 1 site (Créteil) |
| Trial ID | NCT04743609 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Créteil
- ACTIV — Créteil, France (RECRUITING)
Study contacts
- Study coordinator: Corinne Levy, MD
- Email: corinne.levy@activ-france.fr
- Phone: 0033148850404
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: RSV Infection, Children, Only, Outpatient, Otitis, RSV, children, otitis with or without concomitant bronchiolitis