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BREF: Resistant Bacteria in Children in France

Sponsor
Association Clinique Thérapeutique Infantile du val de Marne (Other)
Overall Status
Recruiting
CT.gov ID
NCT06036628
Collaborator
(none)
1,000
Enrollment
1
Location
24
Anticipated Duration (Months)
41.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is observational, multicenter and prospective study for surveillance of the use of new antibiotics in pediatrics for treated pediatrics infections due to multi-resistant bacteria

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The main of this study is to evaluate the relevance of prescribing "new antibiotics" according to the antibiogram of the isolated bacteria or in the absence of bacteriological documentation

    As this is a surveillance study, the clinical and biological characteristics of the children included will be described.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    National Surveillance of the Use of New Antibiotics in Pediatrics and Multi- Resistant Bacteria Involved in Pediatric Infections
    Actual Study Start Date :
    Apr 1, 2023
    Anticipated Primary Completion Date :
    Mar 31, 2025
    Anticipated Study Completion Date :
    Mar 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Relevance of prescribing "new antibiotics" according to the antibiogram of the isolated bacteria or in the absence of bacteriological documentation [1 year]

      Type of new antibiotics prescribed for pediatrics infections caused by multi-resistant bacteria, and how are they used

    Secondary Outcome Measures

    1. Describe Bacterial epidemiology of infections associated with prescription of new antibiotics [1 year]

      Characteristic of bacteria associated with prescription of new antibiotics

    2. Identify Risks factors for multi-resistant bacteria [1 year]

      Type of conditions responsible of multi-resistant such as comorbidities, travel, previous hospitalization, previous antibiotherapy,

    3. Discribe Context of drug Prescription [1 year]

      Number, type of departement involved and How antibiotics prescriptions are controlled and validated

    4. Describe Associated Antibiotherapies [1 year]

      Number and type of drug association prescribed

    5. Describe patients outcome [1 year]

      Proportion of patients clinically and bacteriologically recovered

    Eligibility Criteria

    Criteria

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

    • Children under 18 years of age

    • Hospitalized in France in a hospital center working with the ACTIV/GPIP network

    • Treated with one or more of the following antibiotics:

    • Colimycin (Colistimethate sodium)

    • Cefiderocol

    • Aztreonam in combination

    • Ceftolozane-Tazobactam

    • Ceftazidime-avibactam

    • Meropenem/vaborbactam

    • Imipenem/Relebactam

    • Tigecycline

    • Daptomycin

    • Ceftaroline fosamil

    • Tedizolid phosphate

    • Fidaxomicin

    • Ceftobiprole

    • Dalbavancin

    In association with a documented infection performed by:

    • Blood culture

    • Normally sterile site

    • Cerebrospinal fluid

    • Pleural fluid

    • Pleura

    • Peritoneum

    • Joint fluid

    • Other

    • Urine sampling if the bacteria was considered responsible for the infection (associated with a leukocyturia ≥10,0000)

    • Respiratory specimens if the bacteria was considered responsible for the infection

    • Sampling on material such as:Intubation probe, Orthopedic, Urological, Central Nervous System (CNS),....

    • Related to colonization with multidrug-resistant bacteria without documentation.

    Exclusion Criteria:

    • Refusal of participation by the patient or his/her parent

    • Medical history of mucoviscidosis

    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

    • Study Director: Levy Corinne, Association Clinique Thérapeutique Infantile du val de Marne
    • Principal Investigator: Cohen Robert, Association Clinique Thérapeutique Infantile du val de Marne

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Association Clinique Thérapeutique Infantile du val de Marne
    ClinicalTrials.gov Identifier:
    NCT06036628
    Other Study ID Numbers:
    • BREF
    First Posted:
    Sep 14, 2023
    Last Update Posted:
    Sep 14, 2023
    Last Verified:
    Sep 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

    Study Results

    No Results Posted as of Sep 14, 2023