Delayed Bronchiolitis Epidemic in French Primary Care Setting Driven by Respiratory Syncytial Virus: Preliminary Data from the Oursyn Study, March 2021.
Alexis Rybak, Corinne Levy, Camille Jung...
https://pubmed.ncbi.nlm.nih.gov/34260480Actively Recruiting
Phase Not Applicable
Age: 1Day - 24Months
All Genders
ID04743609
Ambulatory Respiratory Tract Infection Survey to Document the Burden of Respiratory Syncytial Virus in Children Under 2 Years
Led by Association Clinique Thérapeutique Infantile du val de Marne · Updated on 2026-03-19
1900
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Association Clinique Thérapeutique Infantile du val de Marne
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the burden of Respiratory Syncytial Virus (RSV) infections in young children under 2 years old in outpatient settings. The study aims to strengthen surveillance of lower respiratory tract infections (LRTI) by adding laboratory testing for RSV, Influenza, and SARS-CoV-2, and by following the patient journey for five years after their first medical visit. It also reviews electronic data from three previous seasons to understand the impact of RSV-related LRTI before enhanced surveillance began. The study involves children presenting with acute otitis media, with or without bronchiolitis, who undergo rapid antigen diagnostic testing using nasopharyngeal swabs for RSV, Influenza, and SARS-CoV-2. Two groups are included: one with otitis media associated with bronchiolitis, and another with otitis media without bronchiolitis. The study is observational and non-randomized, focusing on outpatient pediatric care. Participants will be assessed at enrollment and followed up at 15 days and six months to document patient care pathways, quality of life scores, and socioeconomic impacts such as parental work absenteeism. Researchers will collect demographic and clinical data, monitor the frequency of otitis media with or without bronchiolitis due to RSV, and evaluate the proportion of cases attributable to RSV and SARS-CoV-2. The total participation period includes initial testing and follow-up assessments to understand long-term outcomes.
CONDITIONS
Brief Title
RSV Burden in Outpatient and Hospital Settings
Who Can Participate
Age: 1Day - 24Months
All Genders
Eligibility Criteria
You may qualify if you...
- Children under 24 months of age (≤ 24 months)
- One of the holders of parental authority has signed consent
- Patient is affiliated with a social security scheme (Social Security or Universal Medical Coverage)
- Acute purulent otitis media (Paradise Criteria) or otorrhea with or without associated bronchiolitis
You will not qualify if you...
- Age greater than 24 months
- Refusal by one of the parents
- Not affiliated with a social security system
- Maternal RSV vaccination during the pregnancy of the included child
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for rapid antigen diagnostic testing using a nasopharyngeal swab
Diagnostic Evaluation
Duration - Day of enrollment
Participants undergo rapid antigen testing for respiratory syncytial virus (RSV), influenza viruses, and SARS-CoV-2 to document the presence of infection.
1 visit (in-person) on the day of enrollment
Long-term Monitoring
Duration - 6 months after inclusion
Participants are followed to document patient care pathways, quality of life, and socioeconomic impact related to otitis media and bronchiolitis over time.
Visits at 15 days and 6 months after inclusion
Trial Site Locations
Total: 1 location
1
ACTIV
Créteil, France, 94000
Actively Recruiting
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Research Team
C
Corinne Levy, MD
S
Stéphane Béchet, MsC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Published Research Related To This Trial
Nirsevimab effectiveness on paediatric emergency visits for RSV bronchiolitis: a test-negative design study.
Lea Lenglart, Corinne Levy, Romain Basmaci...
https://pubmed.ncbi.nlm.nih.gov/39893316Assessing 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.
Alexis Rybak, Robert Cohen, Mathieu Bangert...
https://pubmed.ncbi.nlm.nih.gov/38900603Effectiveness of Nirsevimab on Primary Care Visits for Respiratory Syncytial Virus-Associated Acute Otitis Media in Infants.
Lea Lenglart, Corinne Levy, Christophe Batard...
https://pubmed.ncbi.nlm.nih.gov/41862086