Children, Only, Otitis, Outpatient, RSV Infection
Conditions
Keywords
RSV, children, otitis with or without concomitant bronchiolitis
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
Interventions
DIAGNOSTIC_TESTnasopharyngeal samples
rapid antigen test for Sars Cov-2, influenza and RSV.
Sponsors
Association Clinique Thérapeutique Infantile du val de Marne
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
A nasopharyngeal specimen will be obtained from the eligible child. The procedure consists of inserting and gently rotating a swab into the posterior nasopharynx to perform a rapid antigen test (nasopharyngeal or nasal). The test provides results within 10 to 15 minutes and determines the presence or absence of respiratory syncytial virus (RSV), influenza viruses, and SARS-CoV-2.
Eligibility
Sex/Gender
ALL
Age
1 Days to 24 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of otitis media associated or not with bronchiolitis due to RSV in outpatient pediatrics | day of enrollment | Number of children presenting with confirmed otitis media, with or without bronchiolitis, attributable to respiratory syncytial virus (RSV) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of RSV positive acute otitis media cases with or without associated bronchiolitis in outpatient settings | day of enrollment | Percentage of children with acute otitis media (OMA) testing positive for RSV, with or without concomitant bronchiolitis |
| Impact of Nirsevimab on the burden of otitis media with or without bronchiolitis in outpatients | day of enrollment | Assessment of the effect of nirsevimab prophylaxis on the frequency and severity of otitis media, with or without bronchiolitis. |
| Proportion of otitis media cases attributable to SARS-CoV-2 in outpatient settings | day of enrollment | Percentage of otitis media cases associated or not with bronchiolitis caused by SARS-CoV-2. |
| Patient care pathway documentation | day of enrollment, at days 15 and at 6 months after inclusion | Number and type of healthcare non-protocol visits, treatments received, and complications |
| Score of Quality of life | 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. |
| Socioeconomic impact: Parental work absenteeism | 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 |
| Demographic and clinical characteristics of included children | day of enrollment | Analysis of characteristics such as prematurity, comorbidities, and Nirsevimab immunization status |
Countries
France
Contacts
CONTACTCorinne Levy, MD
CONTACTStéphane Béchet, MsC
STUDY_DIRECTORRobert Cohen
Association Clinique et Thérapeutique Infantile du Val de Marne
Outcome results
None listed