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CompletedNCT06054334ISOBKUpdated Jun 12, 2026

Relevance of Isoniazid Dosage in Adults Treated for Tuberculosis

An observational study in Tuberculosis, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Centre Hospitalier Universitaire, Amiens · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
112
Ages
18 Years to 99 Years
Sex
All
01

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.

02

Conditions studied

  • Tuberculosis

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Keywords

  • Isoniazid
  • tuberculosis
  • acetylation
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In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 112 is below the median of 250 across 421 observational studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • pregnancy,
  • disagreement to participate
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
112 participants (actual)
Patient registry
No
06

What researchers measure

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).

    Time frame: between day 15 and day 30

07

Study locations

1 site
  • CHU Amiens Picardie
    Amiens, Picardie 80054, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06054334
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Sep 26, 2023
Start date
Aug 31, 2023
Primary completion
Nov 6, 2025
Completion
Nov 6, 2025
Last update
Jun 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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