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Isoniazid Dose Adjustment According to NAT2 Genotype (IDANAT2)

NCT00571753 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2011-02-28

No results posted yet for this study

Summary

The study is conducted to compare safety and efficacy of isoniazid administered as an adjusted dose based on NAT2 (arylamine N-acetyltransferase type 2)genotype and as a standard dose.

The hypothesis is that the genotype-adjusted dose is superior to the standard dose with regard to hepatotoxicity and early treatment failure, respectively, in the group of slow and rapid acetylators of NAT2.

Conditions

  • Pulmonary Tuberculosis

Interventions

DRUG

isoniazid

modified daily isoniazid dose according to NAT2 genotype (appr. 2.5 mg/kg, 5 mg/kg and 7.5 mg/kg for slow, intermediate and rapid acetylators, respectively).

DRUG

isoniazid

Treatment with a standard isoniazid dose of isoniazid (appr. 5 mg/kg b.w.)

Sponsors & Collaborators

  • University of Cologne

    lead OTHER

Principal Investigators

  • Gerd Fätkenheuer, Prof. Dr. med. · Department I of Internal MedicineUniversity Hospital, University of Cologne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-12-31
Completion
2012-02-29

Countries

  • Bulgaria
  • Germany
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00571753 on ClinicalTrials.gov