Relevance of Isoniazid Dosage in Adults Treated for Tuberculosis - Trial NCT06054334
Access comprehensive clinical trial information for NCT06054334 through Pure Global AI's free database. This phase not specified trial is sponsored by Centre Hospitalier Universitaire, Amiens and is currently Recruiting. The study focuses on Tuberculosis. Target enrollment is 138 participants.
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Study Focus
Observational
Sponsor & Location
Centre Hospitalier Universitaire, Amiens
Timeline & Enrollment
N/A
Jan 04, 2023
Oct 01, 2024
Primary Outcome
Serum isoniazid Cmax
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06054334
Non-Device Trial