Relevance of Isoniazid Dosage in Adults Treated for Tuberculosis

NCT ID: NCT06054334

Last Updated: 2023-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-04

Study Completion Date

2024-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tuberculosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnancy,
* disagreement to participate
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens Picardie

Amiens, Picardie, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Claire ANDREJAK, Pr

Role: CONTACT

03 22 08 79 98

Facility Contacts

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Claire ANDREJAK, PhD

Role: primary

+33322455960

Other Identifiers

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PI2023_843_0003

Identifier Type: -

Identifier Source: org_study_id

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