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Recruiting

NCT Number: NCT04743609

RSV Burden in Outpatient and Hospital Settings

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

Recruiting

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Key information

Conditions

RSV Infection Children, Only Ear Diseases Infections Mononegavirales Infections Otitis Otorhinolaryngologic Diseases Outpatient Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Respiratory Syncytial Virus Infections Virus Diseases

Age range

1 day–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nasopharyngeal samples

Diagnostic Test

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

Primary outcomes

  1. 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

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

    Time frame: day of enrollment

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

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

    Time frame: day of enrollment

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

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

    Time frame: day of enrollment

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

  4. Patient care pathway documentation

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

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

  5. Score of Quality of life

    Time frame: 15 days and 6 months after inclusion

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

  6. Socioeconomic impact: Parental work absenteeism

    Time frame: 15 days and 6 months after inclusion

    Number of days parents miss work due to the child's illness, according to children RSV status and nirsevimab immunization

  7. Demographic and clinical characteristics of included children

    Time frame: day of enrollment

    Analysis of characteristics such as prematurity, comorbidities, and Nirsevimab immunization status

Study contacts

Contact information is provided by the study sponsor or research team.

Corinne Levy, MD

CONTACT

[email protected]

0033148850404

Stéphane Béchet, MsC

CONTACT

[email protected]

0033148850404

Sponsors and collaborators

Lead sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Other

Collaborators

  • Sanofi

Registry information

Official study title

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

Acronym: Oursyn

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 8, 2021
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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