NCT00571753

Isoniazid Dose Adjustment According to NAT2 Genotype (IDANAT2)

A Double-blind, Multicentre, Parallel Group, Randomised, Controlled Trial to Evaluate the Possible Benefit of Isoniazid Dose Adjustment According to the Genotype for NAT2 (Arylamine N-acetyltransferase Type 2) in Patients With Pulmonary Tuberculosis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.)

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-12-01
• Completion: 2012-02-01
• First posted: 2007-12-12
• Last updated: 2011-02-28

Locations

12 sites across 3 countries: Bulgaria, Germany, Poland