Ambulatory Respiratory Tract Infection Survey, Burden of Respiratory Syncitial Virus in the Era of Covid-19
Overview
- Phase
- Not Applicable
- Intervention
- nasopharyngeal samples
- Conditions
- RSV Infection
- Sponsor
- Association Clinique Thérapeutique Infantile du val de Marne
- Enrollment
- 1900
- Locations
- 1
- Primary Endpoint
- Frequency of otitis media associated or not with bronchiolitis due to RSV in outpatient pediatrics
- Status
- Recruiting
- Last Updated
- last month
Overview
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
Investigators
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)
- •Acute purulent otitis media (Paradise Criteria) or otorrhea with or withitout associated bronchiolitis
Exclusion Criteria
- •Age \>24 months
- •Refusal by one of the parents
- •Not affiliated to a social security system
- •Maternal RSV vaccination during the pregnancy of the included child
Arms & Interventions
Otitis associated with Bronchiolitis
Only for city physicians: 800 children presenting with acute otitis media associated with bronchiolitis will undergo a rapid antigen diagnostic test for respiratory syncytial virus (RSV), influenza viruses, and SARS-CoV-2, using a nasopharyngeal swab.
Intervention: nasopharyngeal samples
Otitis not associated with Bronchiolitis
Only for city physicians: A total of 1,100 children presenting with acute otitis media, without concomitant bronchiolitis, will undergo a rapid antigen diagnostic test for respiratory syncytial virus (RSV), influenza viruses, and SARS-CoV-2, using a nasopharyngeal swab.
Intervention: nasopharyngeal samples
Outcomes
Primary Outcomes
Frequency of otitis media associated or not with bronchiolitis due to RSV in outpatient pediatrics
Time Frame: day of enrollment
Number of children presenting with confirmed otitis media, with or without bronchiolitis, attributable to respiratory syncytial virus (RSV)
Secondary Outcomes
- Proportion of RSV positive acute otitis media cases with or without associated bronchiolitis in outpatient settings(day of enrollment)
- Impact of Nirsevimab on the burden of otitis media with or without bronchiolitis in outpatients(day of enrollment)
- Proportion of otitis media cases attributable to SARS-CoV-2 in outpatient settings(day of enrollment)
- Patient care pathway documentation(day of enrollment, at days 15 and at 6 months after inclusion)
- Score of Quality of life(15 days and 6 months after inclusion)
- Socioeconomic impact: Parental work absenteeism(15 days and 6 months after inclusion)
- Demographic and clinical characteristics of included children(day of enrollment)