RSV Burden in Outpatient Settings (Oursyn)

Association Clinique Thérapeutique Infantile du val de Marne

Status: Enrolling

Conditions: Bronchiolitis; RSV Infection; Otitis Media; Children, Only; Pneumonia; Outpatient

Treatments: Diagnostic Test: nasopharyngeal samples

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04743609

2020-A02876-33

Details and patient eligibility

About

Strengthening outpatient low respiratory tract infection surveillance to document the burden of Respiratory Syncytial Virus (RSV)

Full 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

Enrollment: 3,500 estimated patients

Sex: All

Ages: 1 day to 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

3,500 participants in 3 patient groups

Bronchiolitis

Description:

- Children under 24 months of age (≤) with First episode of bronchiolitis. Aims : - For city physicians: Enrrollment of 1000 children with Bronchiolitis not associated with otitis - In the hospital (at pediatric emergencies): Enrrollment of 900 children with bronchiolitis

Treatment:

Diagnostic Test: nasopharyngeal samples

Acute otitis media

Description:

Define with Paradise Criteria) or otorrhea Enrrollment only for city physicians : * 500 children with Otitis not associated with Bronchiolitis * 500 children with Otitis associated with Bronchiolitis

Treatment:

Diagnostic Test: nasopharyngeal samples

Pneumonia

Description:

Defined by the presence of opacity of parenchymal condensation and/or pleural effusion on chest X-ray associated with fever. Aims: - For city physicians: Enrrollment of 100 children with pneumonia - In the hospital (pediatric emergencies): Enrollment of 500 children with pneumonia

Treatment:

Diagnostic Test: nasopharyngeal samples