Efficacy and Safety of High-Dose Rifampin in Pulmonary Tuberculosis. A Randomized Controlled Trial.

ABSTRACT:

Rationale

We examined whether increased rifampin doses could shorten standard therapy for tuberculosis without increased toxicity.

Objectives

To assess the differences across three daily oral doses of rifampin in change in elimination rate of Mycobacterium tuberculosis in sputum and frequency of rifampin-related adverse events.

Methods

We conducted a blinded, randomized, controlled phase 2 clinical trial of 180 adults with new smear-positive pulmonary tuberculosis, susceptible to isoniazid and rifampin. We randomized 1:1:1 to rifampin at 10, 15, and 20 mg/kg/d during the intensive phase. We report the primary efficacy and safety endpoints: change in elimination rate of M. tuberculosis log₁₀ colony-forming units and frequency of grade 2 or higher rifampin-re

SUBMITTER: Velasquez GE 

PROVIDER: S-EPMC6118011 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature