High dose rifampin for 2 months vs standard dose rifampin for 4 months, to treat TB infection: Protocol of a 3-arm randomized trial (2R2).

ABSTRACT:

Introduction

Tuberculosis preventive treatment (TPT) is an essential component for TB elimination. In order to be successfully implemented on a large scale, TPT needs to be safe, affordable and widely available in all settings. Short TPT regimens, that are less burdensome than longer regimens, to patients and health systems, are needed. Doses of rifampin higher than the standard 10mg/kg/day were tolerated in studies to reduce duration of treatment for tuberculosis disease (TBD). The objective of this trial is to test the safety of high dose rifampin monotherapy to shorten the duration of the currently recommended TPT of 4 months rifampin.

Methods and analysis

This is a phase 2b, randomised, controlled, parallel group, superiority, partially-blind trial. Primary outcomes are

SUBMITTER: Fregonese F 

PROVIDER: S-EPMC9894386 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature