High-Dose Isoniazid Adjuvant Therapy for Multidrug Resistant Tuberculosis

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The need for a standardized treatment protocol for multidrug resistant tuberculosis (MDR-TB) in resource-limited countries is being increasingly recognized. This single center, double blind, randomized controlled trial was designed to compare the time required for sputum culture conversion and extent of radiological improvement in cases of MDR pulmonary tuberculosis when isoniazid was included (both at a regular dose and at a high dose) as an adjuvant to the standardized second line of treatment. The study was designed to test the hypothesis that inclusion of high-dose isoniazid will enhance the effectiveness of the second line of treatment in cases of MDR-TB without significantly increasing the toxicity.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GSVM Medical College
• Treatments: Aminosalicylic Acid; Isoniazid

Criteria

Inclusion Criteria:

• Consecutive patients reporting to the study center

• Sputum-positive for acid-fast bacilli

• HIV-uninfected

• MDR-TB defined as resistance to at least the following two drugs: Isoniazid and Rifampicin.

Exclusion Criteria:

• Unwilling to give consent

• Abnormal renal or hepatic profile

• History suggestive of isoniazid hypersensitivity

• Pregnancy

• Lactating mother

• Previous history of taking any of the following: kanamycin, prothionamide, levofloxacin, cycloserine and p-aminosalicylic acid