RSV Burden in Outpatient and Hospital Settings

Association Clinique Thérapeutique Infantile du val de Marne1,900 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

1,900

Conditions

RSV Infection Children, Only Outpatient Otitis

Interventions

nasopharyngeal samplesDIAGNOSTIC_TEST

rapid antigen test for Sars Cov-2, influenza and RSV.

Eligibility

Sex: ALLMin age: 1 DayMax age: 24 Months

Medical Language ↔ Plain English

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

Locations (1)

ACTIV

Créteil, France

RECRUITING

Outcomes

Primary Outcomes

Frequency of otitis media associated or not with bronchiolitis due to RSV in outpatient pediatrics

Number of children presenting with confirmed otitis media, with or without bronchiolitis, attributable to respiratory syncytial virus (RSV)

Time frame: day of enrollment

Secondary Outcomes

Proportion of RSV positive acute otitis media cases with or without associated bronchiolitis in outpatient settings

Percentage of children with acute otitis media (OMA) testing positive for RSV, with or without concomitant bronchiolitis

Time frame: day of enrollment

Impact of Nirsevimab on the burden of otitis media with or without bronchiolitis in outpatients

Assessment of the effect of nirsevimab prophylaxis on the frequency and severity of otitis media, with or without bronchiolitis.

Time frame: day of enrollment

Proportion of otitis media cases attributable to SARS-CoV-2 in outpatient settings

Percentage of otitis media cases associated or not with bronchiolitis caused by SARS-CoV-2.

Time frame: day of enrollment

Patient care pathway documentation

Number and type of healthcare non-protocol visits, treatments received, and complications

Time frame: day of enrollment, at days 15 and at 6 months after inclusion

Score of Quality of life

Health-related quality of life assessed using the PedsQL test, according to RSV status and nirsevimab immunization status.

Time frame: 15 days and 6 months after inclusion

Socioeconomic impact: Parental work absenteeism

Central Contacts

Corinne Levy, MD

CONTACT

0033148850404 corinne.levy@activ-france.fr

Stéphane Béchet, MsC

CONTACT

0033148850404 stephane.bechet@activ-france.fr

Data from ClinicalTrials.gov

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