NCT06054334

Relevance of Isoniazid Dosage in Adults Treated for Tuberculosis

Centre Hospitalier Universitaire, Amiens·ClinicalTrials.govRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Tuberculosis
Study type
Observational
Sponsor & location
Primary sponsor
Centre Hospitalier Universitaire, Amiens
Location
Amiens, France
Timeline & enrollment
Phase
N/A
Start date
Jan 04, 2023
End date
Oct 01, 2024
Enrollment
138 participants
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
TuberculosisLatent tuberculosisTuberculosis of other organsCongenital tuberculosisSequelae of tuberculosis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06054334
Type
Non-Device Trial
About this record

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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