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NCT06054334 Clinical Trial

Relevance of Isoniazid Dosage in Adults Treated for Tuberculosis

Tuberculosis Clinical Trial

— ISOBK  

Official title:
Relevance of Isoniazid Dosage in Adults Treated for Tuberculosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06054334
Other study ID # PI2023_843_0003
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 4, 2023
Est. completion date October 2024

Study information
Verified date September 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Claire ANDREJAK, Pr
Phone 03 22 08 79 98
Email andrejak.claire@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 138
Est. completion date October 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - to be an adult, - to have a diagnosis of tuberculosis Exclusion Criteria: - pregnancy, - disagreement to participate

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU Amiens Picardie Amiens Picardie

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum isoniazid Cmax : Serum isoniazid Cmax in the standards, (i.e., between 3 et 6 µg/ml measured at 1h or 2h). between day 15 and day 30
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