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RSV Burden in Outpatient Settings (Oursyn)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04743609
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : March 22, 2021
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Association Clinique Thérapeutique Infantile du val de Marne

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

Condition or disease Intervention/treatment
RSV Infection Children, Only Outpatient Bronchiolitis Otitis Media Pneumonia Diagnostic Test: nasopharyngeal samples

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 Design
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Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ambulatory Respiratory Tract Infection Survey, Burden of Respiratory Syncitial Virus in the Era of Covid-19
Actual Study Start Date : February 8, 2021
Estimated Primary Completion Date : July 11, 2021
Estimated Study Completion Date : January 11, 2023
Groups and Cohorts
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Group/Cohort Intervention/treatment
Bronchiolitis
- children under 24 months of age (≤) with First episode of bronchiolitis
 Diagnostic Test: nasopharyngeal samples
rapid antigen test for Sars Cov-2, influenza and RSV. RT-PCR for a subgroup of 400 patients
Acute otitis media
define with Paradise Criteria) or otorrhea
 Diagnostic Test: nasopharyngeal samples
rapid antigen test for Sars Cov-2, influenza and RSV. RT-PCR for a subgroup of 400 patients
Pneumonia
defined by the presence of opacity of parenchymal condensation and/or pleural effusion on chest X-ray associated with fever
 Diagnostic Test: nasopharyngeal samples
rapid antigen test for Sars Cov-2, influenza and RSV. RT-PCR for a subgroup of 400 patients


Outcome Measures
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Primary Outcome Measures :
  1. RSV proven [ Time Frame: day of enrrollement ]
    Percentage of children with proven RSV disease (bronchiolitis, AOM or pneumonia)


Secondary Outcome Measures :
  1. Proportion of Respiratory Tract Infections by RSV Status [ Time Frame: day of enrrollement ]
    Percentage of children with Respiratory Tract Infections by RSV Status

  2. 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

  3. 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

  4. Proportion of AOM by RSV status [ Time Frame: day of enrrollement ]
    Percentage of children with AOM by RSV status

  5. Proportion of pneumonia by RSV status [ Time Frame: day of enrrollement ]
    Percentage of children with pneumonia by RSV status

  6. 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)

  7. 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


Biospecimen Retention:   Samples Without DNA
Nasopharyngeal samples : rapid antigen test: Sars cov2, influenza and RSV

Eligibility Criteria
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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
children under 24 months old with first episode of bronchiolitis or acute otitis media or pneumonia
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04743609


Contacts
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Contact: Corinne Levy, MD 0033148850404 corinne.levy@activ-france.fr
Contact: Stéphane Béchet, MsC 0033148850404 stephane.bechet@activ-france.fr

Locations
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France
ACTIV Recruiting
Créteil, France, 94000
Contact: Corinne Levy, MD    0033148850404    corinne.levy@activ-france.fr   
Contact: Stéphane Béchet, MSc    0033148850404    stephane.bechet@activ-france.fr   
Sponsors and Collaborators
Association Clinique Thérapeutique Infantile du val de Marne
Sanofi
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Association Clinique Thérapeutique Infantile du val de Marne
ClinicalTrials.gov Identifier: NCT04743609    
Other Study ID Numbers: 2020-A02876-33
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Association Clinique Thérapeutique Infantile du val de Marne:
RSV
children
bronchiolitis
otitis
pneumonia
Additional relevant MeSH terms:
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Infections
Pneumonia
Bronchiolitis
Respiratory Syncytial Virus Infections
Otitis
Otitis Media
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Bronchitis
 Bronchial Diseases
Lung Diseases, Obstructive
Ear Diseases
Otorhinolaryngologic Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases