SimpliciTB

SimpliciTB

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 as a potential treatment 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 DS-TB and DR-TB treatment.

SimpliciTB is funded in part by the European and Developing Countries Clinical Trials Partnership (EDCTP) through a grant to the University of St. Andrews

Additional Resources

Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients. ClinicalTrials.gov Identifier: NCT03338621

A Phase 2 Open Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis. (NC-005)

Efficacy of Bedaquiline, Pretomanid, Moxifloxacin & PZA (BPaMZ) against DS- & MDR-TB. (NC-005)

SimpliciTB Page on the University of St. Andrews TB Trials Website

Download the SimpliciTB Fact Sheet

Stage of Development:

Phase 3

Trial Compounds

This trial has the following compounds:

No related compounds found for this trial.

Trial Regimens

This trial has the following regimens: