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

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ACTIV

Créteil, France, 94000