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ISOBK: Relevance of Isoniazid Dosage in Adults Treated for Tuberculosis

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT06054334
Collaborator
(none)
138
Enrollment
1
Location
20.9
Anticipated Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Tuberculosis is the third leading infectious killer. In 2021, an estimated 10,6 million people fell ill with tuberculosis worldwide. Drug resistance emerges with the increase of antibiotherapy use. Among the four antimicrobial drugs used for tuberculosis, isoniazid is a first line treatment. It has a bactericidal activity against the tuberculosis complex. Nevertheless, the hepatic metabolism of isoniazid shows variation between individuals. There is a real risk of hepatotoxicity and neurotoxicity induced by isoniazid. The peak measurement (Cmax) of serum isoniazid is recommended to adjust the treatment and to allow recovery. Moreover, several samples allow a kinetics of isoniazid elimination so as to distinguish slow and fast acetylators. Few data are available on isoniazid acetylation. It could be useful to know the proportion of patients treated by isoniazid at a standard dose, associated with a risk of overdosing or underdosing. Inadequate exposures should be studied to understand if there is an impact in the medical care.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    138 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Relevance of Isoniazid Dosage in Adults Treated for Tuberculosis
    Actual Study Start Date :
    Jan 4, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Oct 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Serum isoniazid Cmax [between day 15 and day 30]

      : Serum isoniazid Cmax in the standards, (i.e., between 3 et 6 µg/ml measured at 1h or 2h).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • to be an adult,

    • to have a diagnosis of tuberculosis

    Exclusion Criteria:

    • pregnancy,

    • disagreement to participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Amiens Picardie Amiens Picardie France 80054

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire, Amiens

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire, Amiens
    ClinicalTrials.gov Identifier:
    NCT06054334
    Other Study ID Numbers:
    • PI2023_843_0003
    First Posted:
    Sep 26, 2023
    Last Update Posted:
    Oct 2, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire, Amiens
    Isoniazid
    tuberculosis
    acetylation
    Additional relevant MeSH terms:
    Tuberculosis

    Study Results

    No Results Posted as of Oct 2, 2023