RSV Burden in Outpatient Settings

Recruiting

• Conditions: Outpatient; RSV Infection; Otitis Media; Children, Only; Bronchiolitis; Pneumonia
• Interventions: Diagnostic Test: nasopharyngeal samples

• Registration Number: NCT04743609
• Lead Sponsor: Association Clinique Thérapeutique Infantile du val de Marne

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

Study Timeline

• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-02-04
• Study Start: 2021-02-08
• Study First Posted: 2021-02-08
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-22
• Last Update Posted: 2022-12-27
• Primary Completion: 2024-01-11
• Study Completion: 2024-01-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute otitis media	nasopharyngeal samples	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
Bronchiolitis	nasopharyngeal samples	- 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
Pneumonia	nasopharyngeal samples	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

Primary Outcome Measures

Name	Time	Method
RSV proven	day of enrrollement	Percentage of children with proven RSV disease (bronchiolitis, AOM or pneumonia)

Secondary Outcome Measures

Name	Time	Method
Proportion of associated complications by RSV status	day of enrrollement, 15 days and 6 months	Percentage of children with associated complications by RSV status
Proportion of AOM by RSV status	day of enrrollement	Percentage of children with AOM by RSV status
Proportion of pneumonia by RSV status	day of enrrollement	Percentage of children with pneumonia by RSV status
Score of Quality of life	15 days and 6 months	Assessed by the quality of life infant scale (from 0-100, so that higher scores indicate better Health-Related Quality of Life)
Caracteristic of tests	day of enrrollement	Sensitivity, specificity, positive predictive value, negative predictive value positive and negative likelihood ratio of the SARS-Cov2, influenza A/B and RSV rapid antigenic test compared to the reference test by multiplex RT-PCR
Proportion of Respiratory Tract Infections with SARS-CoV-2	day of enrrollement	Percentage of children with Respiratory Tract Infections with SARS-CoV-2
Proportion of Respiratory Tract Infections by RSV Status	day of enrrollement	Percentage of children with Respiratory Tract Infections by RSV Status

Trial Locations

Locations (1)

ACTIV; 🇫🇷 Créteil, France