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ISAI: Invasive Group A Streptococcal Infection

Sponsor
Association Clinique Thérapeutique Infantile du val de Marne (Other)
Overall Status
Recruiting
CT.gov ID
NCT05788861
Collaborator
(none)
100
Enrollment
1
Location
48
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is observational, retrospective and prospective study in pediatric patients hospitalized with invasive streptococcal A infection

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The main of this study is to identify and record cases of invasive and severe infections due to Streptococcus pyogenes. In order to evaluate the incidence of severe forms of disease and the possible contributing factors, and to optimize their management.

    Admitted patients to intensive care or critical care units in reported via Santé Publique France may also be included in this study.

    Secondly, epidemiological, clinical, bacteriological data of all severe or not cases, of group A Streptococcal infections will be compiled to describe their characteristics, and try to explain this recrudescence as well as possible.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    French Pediatric Nationwide Observatory of Invasive Group A Streptococcal Infection (in Childen for 0 to 18 Ages)
    Actual Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Sep 1, 2026
    Anticipated Study Completion Date :
    Sep 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Hospitalisation [1 year]

      How long patient was hospitalised during this infection

    2. Treatments provided in intensive care unit [1 year]

      what treatments are used in intensive care unit to treat infection

    3. Complications [1 year]

      what are the complications due to severe infection

    4. Treatments used in routine care unit [1 year]

      which treatments are used in routine care unit to treat the infection

    5. Risk factors [1 year]

      description of underlying conditions

    6. Characterization of Group A Streptococcus strains [1 year]

      Characterization of Group A Streptococcus strains by the CNR

    7. Death [1 year]

      Death Outcome during hospitalisation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age<18 years

    • Documented invasive Group A Streptococcus infection (identification of GAS in a normally sterile site or from another site in case of toxin shock or necrotizing dermo-hypodermatitis)

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ACTIV Créteil France 94000

    Sponsors and Collaborators

    • Association Clinique Thérapeutique Infantile du val de Marne

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Association Clinique Thérapeutique Infantile du val de Marne
    ClinicalTrials.gov Identifier:
    NCT05788861
    Other Study ID Numbers:
    • ISAI
    First Posted:
    Mar 29, 2023
    Last Update Posted:
    Mar 29, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Streptococcal Infections

    Study Results

    No Results Posted as of Mar 29, 2023