RSV Burden in Outpatient Settings

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

Detailed Description
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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

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

Conditions
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RSV Infection, Children, Only, Outpatient, Bronchiolitis, Otitis Media, Pneumonia

Intervention / Treatment
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* Diagnostic Test: nasopharyngeal samples


Participation Criteria
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Eligibility Criteria
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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) First episode of bronchiolitis defined by Age ≤24 months At least one symptom from group A and one symptom from group B Group A (one or more) Fever >38 °C Cough Otalgia Nasal congestion Rhinorrhea Coryza Dysphagia Group B (one or more) whistling Crackles Rales Decrease in respiratory noise Shortness of breath Dyspnea OR Acute purulent otitis media (Paradise Criteria) or otorrhea. OR Pneumonia defined by the presence of opacity of parenchymal condensation and/or pleural effusion on chest X-ray associated with fever Exclusion Criteria: Age >24 months Refusal by one of the parents Not affiliated to a social security system

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bronchiolitis<br>- Children under 24 months of age (≤) with First episode of bronchiolitis. Aims : - For city physicians: Enrrollment of 1000 children with Bronchiolitis not associated with otitis - In the hospital (at pediatric emergencies): Enrrollment of 900 children with bronchiolitis | Diagnostic Test: nasopharyngeal samples<br>* rapid antigen test for Sars Cov-2, influenza and RSV. multiplex RT-PCR for a subgroup of 500 patients<br>|
| Acute otitis media<br>Define with Paradise Criteria) or otorrhea Enrrollment only for city physicians : 500 children with Otitis not associated with Bronchiolitis 500 children with Otitis associated with Bronchiolitis | Diagnostic Test: nasopharyngeal samples<br>* rapid antigen test for Sars Cov-2, influenza and RSV. multiplex RT-PCR for a subgroup of 500 patients<br>|
| Pneumonia<br>Defined by the presence of opacity of parenchymal condensation and/or pleural effusion on chest X-ray associated with fever. Aims: - For city physicians: Enrrollment of 100 children with pneumonia - In the hospital (pediatric emergencies): Enrollment of 500 children with pneumonia | Diagnostic Test: nasopharyngeal samples<br>* rapid antigen test for Sars Cov-2, influenza and RSV. multiplex RT-PCR for a subgroup of 500 patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RSV proven | Percentage of children with proven RSV disease (bronchiolitis, AOM or pneumonia) | day of enrrollement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Respiratory Tract Infections by RSV Status | Percentage of children with Respiratory Tract Infections by RSV Status | day of enrrollement | 
| Proportion of Respiratory Tract Infections with SARS-CoV-2 | Percentage of children with Respiratory Tract Infections with SARS-CoV-2 | day of enrrollement | 
| Proportion of associated complications by RSV status | Percentage of children with associated complications by RSV status | day of enrrollement, 15 days and 6 months | 
| Proportion of AOM by RSV status | Percentage of children with AOM by RSV status | day of enrrollement | 
| Proportion of pneumonia by RSV status | Percentage of children with pneumonia by RSV status | day of enrrollement | 
| Score of Quality of life | Assessed by the quality of life infant scale (from 0-100, so that higher scores indicate better Health-Related Quality of Life) | 15 days and 6 months | 
| Caracteristic of tests | Sensitivity, specificity, positive predictive value, negative predictive value positive and negative likelihood ratio of the SARS-Cov2, influenza A/B and RSV rapid antigenic test compared to the reference test by multiplex RT-PCR | day of enrrollement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RSV, children, bronchiolitis, otitis, pneumonia