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

Simplifying treatment for patients with tuberculosis

What is this study about?

Although some progress has been made in recent years in controlling tuberculosis (TB) globally, TB has remained a persistent problem in the developing countries of Africa, Asia and South America.The current first-line antituberculosis agents have been in use for over 40 years and are relatively ineffective in controlling TB as a public health problem because of problems with poor treatment adherence. Drug resistance is becoming more common and fears of an epidemic with virtually untreatable strains of TB are growing. Since the discovery of the rifamycins, and their introduction into standard antituberculosis regimens, very few new classes of drugs have been evaluated with a view to their registration as antituberculosis agents.

SimpliciTB trial is a phase 3 open-label partially randomised clinical trial to evaluate the efficacy, safety and tolerability of a new regimen which combines moxifloxacin plus bedaqualine plus a new agent, pretomanid, plus pyrazinamide (BPaMZ) given for 4 or 6 months.  Drug sensitive (DS) patients are randomised 1:1 to either 4 month of BPaMZ or to 6 months of standard first line TB treatment (HRZE). Drug resistant (DR) patients are enrolled and treated for 6 months of BPaMZ

Type of study

Randomised trial

Who is funding the study?

Global Alliance for TB Drug Development

When is it taking place?

Recruitment started in July 2018 and results are expected in 2022.

Where is it taking place?

The trial is currently recruiting in South Africa, Tanzania, Uganda, Georgia and Malaysia.

Who is included?

300 drug-sensitive (DS) and up to 150 drug-resistant (DR) TB patients