Trial

Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients

Study Director
Start Date
7 / 2018
Trial Phase
Phase II
Trial Status
enrolling
Current Enrollment
15 (October 2018)
Target Enrollment
450
Overview

SimpliciTB is evaluating the efficacy, safety and tolerability of a novel and potentially shorter drug regimen (BPaMZ) for patients with drug-sensitive (DS) and drug-resistant (MDR) pulmonary tuberculosis (specifically multidrug-resistant TB and mono-resistance to isoniazid and rifampicin). The BPaMZ regimen is comprised of four different antimicrobials: Bedaquiline (B), Pretomanid (Pa), Moxifloxacin (M) and Pyrazinamide (Z). The new drug regimen will be administered for four months to patients with DS-TB, and for six months to patients with MDR-TB or mono-resistance to rifampicin or isoniazid. Results in the DS-TB arm will be compared to a control group of the standard six-month drug regimen for DS-TB (HRZE).

Background:

Overview/Background

Tuberculosis treatment requires the combination of several antimicrobial drugs to achieve maximal efficacy.  This is the result of many factors, including the general resistance of M. tuberculosis to several drugs due to its structure and metabolism, its ability to persist in the body by residing in the cells that would normally kill them and its tendency to develop resistance to drug therapy. 

In the SimpliciTB trial, TB Alliance is testing a novel combination antimicrobial therapy called BPaMZ. This drug regimen, consisting of bedaquiline, pretomanid, moxifloxacin and pyrazinamide is being studied to determine an impactful treatment with the potential to transform TB therapy for both DS-TB and DR-TB. 

SimpliciTB is a pivotal, multi-center, open-label partially randomized clinical trial. It is targeting at least 26 centers in 10 countries in Africa, Asia, Europe and South America. A total of 450 participants (150 per treatment group) will be enrolled and assigned to the following treatment arms:

  • Participants with DS-TB will receive BPaMZ daily for 4 months;
  • Participants with DS-TB will receive HRZE/HR combination tablets daily for 6 months; and
  • Participants with DR-TB (MDR-TB as well as mono-resistance to isoniazid or rifampicin) will receive BPaMZ daily for 6 months.

The all-oral BPaMZ drug regimen tested in SimpliciTB is being evaluated for its potential to shorten treatment to a duration more easily manageable by patients and public health services, and to provide a more effective, safer and affordable treatment for the growing number of patients suffering from drug-resistant TB.