Status:
UNKNOWN
RSV Burden in Outpatient Settings
Lead Sponsor:
Association Clinique Thérapeutique Infantile du val de Marne
Collaborating Sponsors:
Sanofi
Conditions:
RSV Infection
Children, Only
Eligibility:
All Genders
1-24 years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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)
- First episode of bronchiolitis defined by
- Age ≤24 months
- At least one symptom from group A and one symptom from group B Group A (one or more)
- Fever \>38 °C
- Cough
- Otalgia
- Nasal congestion
- Rhinorrhea
- Coryza
- Dysphagia Group B (one or more)
- whistling
- Crackles
- Rales
- Decrease in respiratory noise
- Shortness of breath
- Dyspnea
- OR Acute purulent otitis media (Paradise Criteria) or otorrhea.
- OR Pneumonia defined by the presence of opacity of parenchymal condensation and/or pleural effusion on chest X-ray associated with fever
Exclusion
- Age \>24 months
- Refusal by one of the parents
- Not affiliated to a social security system
Key Trial Info
Start Date :
February 8 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 11 2024
Estimated Enrollment :
3500 Patients enrolled
Trial Details
Trial ID
NCT04743609
Start Date
February 8 2021
End Date
January 11 2024
Last Update
December 27 2022
Active Locations (1)
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1
ACTIV
Créteil, France, 94000