RSV Burden in Outpatient and Hospital Settings (Oursyn)

Association Clinique Thérapeutique Infantile du val de Marne

Status

Enrolling

Conditions

RSV Infection

Otitis

Children, Only

Outpatient

Treatments

Diagnostic Test: nasopharyngeal samples

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04743609

2020-A02876-33

Details and patient eligibility

About

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

Full 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

Enrollment

1,900 estimated patients

Sex

All

Ages

1 day to 24 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

1,900 participants in 2 patient groups

Otitis associated with Bronchiolitis

Experimental group

Description:

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.

Treatment:

Diagnostic Test: nasopharyngeal samples

Otitis not associated with Bronchiolitis

Experimental group

Description:

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.

Treatment:

Diagnostic Test: nasopharyngeal samples

Trial contacts and locations

Central trial contact

Stéphane Béchet, MsC; Corinne Levy, MD

Data sourced from clinicaltrials.gov

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