Relevance of Isoniazid Dosage in Adults Treated for Tuberculosis

Last updated: September 28, 2023
Sponsor: Centre Hospitalier Universitaire, Amiens
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv

Lung Disease

Treatment

N/A

Clinical Study ID

NCT06054334
PI2023_843_0003
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • to be an adult,
  • to have a diagnosis of tuberculosis

Exclusion

Exclusion Criteria:

  • pregnancy,
  • disagreement to participate

Study Design

Total Participants: 138
Study Start date:
January 04, 2023
Estimated Completion Date:
October 31, 2024

Connect with a study center

  • CHU Amiens Picardie

    Amiens, Picardie 80054
    France

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.