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VIGIL: Use of PCR-Sars-CoV-2 in Children

Sponsor
Centre Hospitalier Intercommunal Creteil (Other)
Overall Status
Recruiting
CT.gov ID
NCT04412317
Collaborator
Association Clinique Thérapeutique Infantile du val de Marne (Other), GPIP (Other), AFPA (Other), Francophone Pediatric Resuscitation and Emergency Group (GFRUP) (Other)
600
Enrollment
2
Locations
11.9
Anticipated Duration (Months)
300
Patients Per Site
25.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In order to clarify the current management of young sick children in France, whether or not they are cared for in community settings (nursery, schools), paediatricians have proposed an algorithm whose objective is to help define the indications for PCR-Sars-CoV-2 (https://www.infovac.fr/actualites/bulletin-special-mai-2020).

This algorithm, in two parts, can be used, when symptoms are detected in children, to orient and guide :

  • first, parents and community personnel to recognize the signs of infection call signs that should involve medical consultation;

  • but also, the physicians who will carry out this medical evaluation and will have to decide whether or not PCR screening is necessary, in parallel with their diagnostic and therapeutic management, which should not be altered in this particular context

Our main objective is to describe, after the confinement phase, the management of young sick children in the community (crèches, nursery and elementary schools, etc.) or not in order to best define the indications for PCR-Sars-CoV-2

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    National Observatory of the Care of Young Sick Children in Community or Not, Indications and Cost-effectiveness of PCR-Sars-CoV-2 - VIGIL Study
    Actual Study Start Date :
    Jun 3, 2020
    Anticipated Primary Completion Date :
    May 30, 2021
    Anticipated Study Completion Date :
    May 31, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Children < 15 years old

    Patients under 15 years old who consults a physician on an outpatient basis or in the emergency room and who requires a Sars-CoV-2 RT- PCR (nucleic acid using real-time reverse-transcriptase polymerase-chain-reaction) diagnostic

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of children screened with a positive PCR result or a positive Rapid Antigenic Diagnostic (RAD) test [the day of PCR/RAD result]

    Secondary Outcome Measures

    1. Percentage of PCR-Sars-CoV-2 positive in the sick child in the presence of a Covid contagion in the family environment or not [the day of PCR result]

    2. Percentage of RAD-Sars-CoV-2 positive in the sick child in the presence of a Covid contagion in the family environment or not [the day of PCR result]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 14 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Children under 15 years of age

    • Prescription of a PCR-Sars-CoV-2

    • VIGIL information note given to parents

    Exclusion Criteria:
    • Refusal to participate by the patient, family member or legal representative (depending on the situation)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ACTIV network Créteil France
    2 PARI network Créteil France

    Sponsors and Collaborators

    • Centre Hospitalier Intercommunal Creteil
    • Association Clinique Thérapeutique Infantile du val de Marne
    • GPIP
    • AFPA
    • Francophone Pediatric Resuscitation and Emergency Group (GFRUP)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Intercommunal Creteil
    ClinicalTrials.gov Identifier:
    NCT04412317
    Other Study ID Numbers:
    • VIGIL
    First Posted:
    Jun 2, 2020
    Last Update Posted:
    Feb 25, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Feb 25, 2021