Relevance of Isoniazid Dosage in Adults Treated for Tuberculosis

NCT06054334 | Completed

• 1 other identifier: PI2023_843_0003
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

Isoniazid; tuberculosis; acetylation

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This clinical study aims to examine the relevance of isoniazid dosage in adults treated for tuberculosis.

You may qualify if:

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

You may not qualify if:

• pregnancy,
• disagreement to participate

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 26, 2023
• Study Start: August 31, 2023
• Primary Completion: November 6, 2025
• Study Completion: November 6, 2025
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)