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Free Content A randomised controlled trial of high-dose isoniazid adjuvant therapy for multidrug-resistant tuberculosis

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SETTING: Tertiary care hospital in Kanpur, India.

BACKGROUND: The need for a standardised treatment protocol for multidrug-resistant tuberculosis (MDR-TB) in resource-limited countries is being increasingly recognised.

OBJECTIVE: To assess the effectiveness of high-dose isoniazid (INH) (16–18 mg/kg) adjuvant to second-line therapy in documented cases of MDR-TB.

DESIGN: The present study is a double blind, randomised controlled trial with three treatment arms, high-dose INH, normal-dose INH and placebo, in addition to second-line drugs. Primary outcomes of the study were time to sputum culture conversion and proportion with sputum culture negative 6 months after treatment initiation. Secondary outcomes were radiological improvement at 1 year post treatment and development of toxicity.

RESULTS: After adjustment for potential confounders, subjects who received high-dose INH became sputum-negative 2.38 times (95%CI 1.45–3.91, P = 0.001) more rapidly than those who did not receive it, and had a 2.37 times (95%CI 1.46–3.84, P < 0.001) higher likelihood of being sputum-negative at 6 months. These subjects showed significantly better radiological improvement without an increased risk of INH toxicity.

CONCLUSION: In low-resource scenarios where a standardised therapeutic protocol is used for MDR-TB, the protocol can be significantly improved by including high-dose INH as an adjuvant.

Keywords: isoniazid; multidrug-resistant tuberculosis; randomised controlled trial

Document Type: Regular Paper

Affiliations: 1: Department of Tuberculosis & Respiratory Diseases, Ganesh Shankar Vidyarthi Memorial Medical College, Kanpur, India 2: Department of Tuberculosis & Respiratory Diseases, Ganesh Shankar Vidyarthi Memorial Medical College, Kanpur, India; and Lata Medical Research Foundation, Nagpur, India 3: Lata Medical Research Foundation, Nagpur, India

Publication date: February 1, 2008

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  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.

    Certain IJTLD articles are selected for translation into French, Spanish, Chinese or Russian. They are available on the Union website

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