Clinical trial NCT04743609: RSV Burden in Outpatient Settings
Official title: Ambulatory Respiratory Tract Infection Survey, Burden of Respiratory Syncitial Virus in the Era of Covid-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: RSV Infection
Children, Only
Outpatient
Bronchiolitis
Otitis Media
Pneumonia
Keywords: RSV
children
bronchiolitis
otitis
pneumonia
Lead sponsor: Association Clinique Thérapeutique Infantile du val de Marne
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2021-02-08
Enrollment: 3500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children under 24 months old with first episode of bronchiolitis or acute otitis media or pneumonia

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) 2. Follow all bronchiolitis through the PARI RWE database and document "patient journey" for 5 years after first medical visit 3. Review the electronic PARI data of three previous seasons in order to document the impact of LRTI attributable to RSV in children \< 2 years in France prior to enhanced surveillance

Eligibility 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)
* 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 Criteria:

* Age \>24 months
* Refusal by one of the parents
* Not affiliated to a social security system

Primary outcomes:
measure: RSV proven
timeFrame: day of enrrollement
Secondary outcomes:
measure: Proportion of Respiratory Tract Infections by RSV Status
timeFrame: day of enrrollement
measure: Proportion of Respiratory Tract Infections with SARS-CoV-2
timeFrame: day of enrrollement
measure: Proportion of associated complications by RSV status
timeFrame: day of enrrollement, 15 days and 6 months
measure: Proportion of AOM by RSV status
timeFrame: day of enrrollement
measure: Proportion of pneumonia by RSV status
timeFrame: day of enrrollement
measure: Score of Quality of life
timeFrame: 15 days and 6 months
measure: Caracteristic of tests
timeFrame: day of enrrollement
Other outcomes:
Locations:
city: Créteil
country: France
facility: ACTIV
Study officials:
References:
citation: Rybak A, Levy C, Jung C, Bechet S, Batard C, Hassid F, Zouari M, Cahn-Sellem F, Bangert M, Cohen R. Delayed Bronchiolitis Epidemic in French Primary Care Setting Driven by Respiratory Syncytial Virus: Preliminary Data from the Oursyn Study, March 2021. Pediatr Infect Dis J. 2021 Dec 1;40(12):e511-e514. doi: 10.1097/INF.0000000000003270.