RSV Burden in Outpatient Settings (Oursyn)

December 22, 2022 updated by: Association Clinique Thérapeutique Infantile du val de Marne

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

children under 24 months old with first episode of bronchiolitis or acute otitis media or pneumonia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bronchiolitis

- 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
rapid antigen test for Sars Cov-2, influenza and RSV. multiplex RT-PCR for a subgroup of 500 patients
Acute otitis media

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
rapid antigen test for Sars Cov-2, influenza and RSV. multiplex RT-PCR for a subgroup of 500 patients
Pneumonia

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
rapid antigen test for Sars Cov-2, influenza and RSV. multiplex RT-PCR for a subgroup of 500 patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RSV proven
Time Frame: day of enrrollement
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
Time Frame: day of enrrollement
Percentage of children with Respiratory Tract Infections by RSV Status
day of enrrollement
Proportion of Respiratory Tract Infections with SARS-CoV-2
Time Frame: day of enrrollement
Percentage of children with Respiratory Tract Infections with SARS-CoV-2
day of enrrollement
Proportion of associated complications by RSV status
Time Frame: day of enrrollement, 15 days and 6 months
Percentage of children with associated complications by RSV status
day of enrrollement, 15 days and 6 months
Proportion of AOM by RSV status
Time Frame: day of enrrollement
Percentage of children with AOM by RSV status
day of enrrollement
Proportion of pneumonia by RSV status
Time Frame: day of enrrollement
Percentage of children with pneumonia by RSV status
day of enrrollement
Score of Quality of life
Time Frame: 15 days and 6 months
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
Time Frame: day of enrrollement
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Collaborators

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2021

Primary Completion (Anticipated)

January 11, 2024

Study Completion (Anticipated)

January 11, 2024

Study Registration Dates

First Submitted

January 20, 2021

First Submitted That Met QC Criteria

February 4, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Actual)

December 27, 2022

Last Update Submitted That Met QC Criteria

December 22, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A02876-33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumonia

Clinical Trials on nasopharyngeal samples

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe