Trial

Evaluating a New Treatment Regimen for Patients With Multidrug-resistant TB (MDR-TB) - a Prospective Open-label Randomised Controlled Trial (Open Label)

Study Director
Keertan Dheda
Start Date
10 / 2015
Trial Phase
Phase III
Trial Status
enrolling
Current Enrollment
Target Enrollment
300
Overview

Experimental: Interventional treatment 6-9 months

Participants will receive six to nine months of oral:

Linezolid 600mg daily (reduce to 300mg if toxicity occurs), Bedaquiline 400mg for 2 weeks, followed by 200mg three times per week, Levofloxacin 750mg (<50kg) or 1000mg (>50kg) daily, PZA 1000-1750mg (40-50kg) or 1750-2000mg (51-70kg) or 2000-2500mg (71-90kg) daily, Ethionamide 15mg/kg (max 900mg) daily, or high-dose Isoniazid 500mg (40-50kg) or 750mg (51-70kg) or 750-1000mg (71-90kg) daily, or Terizidone 750mg (40-70kg) or 750-1000mg (71-90kg) daily.

A gene-directed diagnostic approach will be used in the interventional arm to individualise therapy and to inform on the use of high dose INH versus ethionamide. Treatment will stop after 3 consecutive negative sputum cultures.