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Recruiting NCT04743609

RSV Burden in Outpatient and Hospital Settings

No phase Interventional RSV Infection Children, Only Outpatient Otitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: nasopharyngeal samples.
Who it may be relevant to
Registry conditions: RSV Infection, Children, Only, Outpatient, Otitis. Basic parameters: 1 Day — 24 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Ambulatory Respiratory Tract Infection Survey, Burden of Respiratory Syncitial Virus in the Era of Covid-19

Overview

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

Interventions

  • Diagnostic test nasopharyngeal samples
    rapid antigen test for Sars Cov-2, influenza and RSV.

Primary outcome measures

  • Frequency of otitis media associated or not with bronchiolitis due to RSV in outpatient pediatrics [Time frame: day of enrollment]
Secondary outcome measures (7)
  • Proportion of RSV positive acute otitis media cases with or without associated bronchiolitis in outpatient settings [Time frame: day of enrollment]
  • Impact of Nirsevimab on the burden of otitis media with or without bronchiolitis in outpatients [Time frame: day of enrollment]
  • Proportion of otitis media cases attributable to SARS-CoV-2 in outpatient settings [Time frame: day of enrollment]
  • Patient care pathway documentation [Time frame: day of enrollment, at days 15 and at 6 months after inclusion]
  • Score of Quality of life [Time frame: 15 days and 6 months after inclusion]
  • Socioeconomic impact: Parental work absenteeism [Time frame: 15 days and 6 months after inclusion]
  • Demographic and clinical characteristics of included children [Time frame: day of enrollment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • ACTIV — Créteil

Publications

  • 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. PMID 34260480
  • Lenglart L, Levy C, Basmaci R, Levieux K, Kramer R, Mari K, Bechet S, Launay E, Cohen L, Aupiais C, de Pontual L, Rybak A, Lassoued Y, Ouldali N, Cohen R. Nirsevimab effectiveness on paediatric emergency visits for RSV bronchiolitis: a test-negative design study. Eur J Pediatr. 2025 Feb 1;184(2):171. doi: 10.1007/s00431-025-06008-9. PMID 39893316
  • Rybak A, Cohen R, Bangert M, Kramer R, Delobbe JF, Deberdt P, Cahn-Sellem F, Bechet S, Levy C. Assessing the Burden of Respiratory Syncytial Virus-related Bronchiolitis in Primary Care and at 15-Day and 6-Month Follow-up Before Prophylaxis in France: A Test-negative Study. Pediatr Infect Dis J. 2024 Jul 1;43(7):657-662. doi: 10.1097/INF.0000000000004360. Epub 2024 Apr 10. PMID 38900603
  • Lenglart L, Levy C, Batard C, Delobbe JF, Lecailler F, Bechet S, Fafi I, Boulhol M, Kramer R, Rybak A, Ouldali N, Cohen R. Effectiveness of Nirsevimab on Primary Care Visits for Respiratory Syncytial Virus-Associated Acute Otitis Media in Infants. J Pediatr. 2026 Jul;294:115067. doi: 10.1016/j.jpeds.2026.115067. Epub 2026 Mar 19. PMID 41862086

Identifiers

NCT: NCT04743609 · 2020-A02876-33

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗