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 anti-tuberculosis medicines 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 anti-TB regimens, very few new classes of drugs have been evaluated with a view to registering them as anti-TB drugs.

SimpliciTB trial is a phase III, open-label, partially-randomised clinical trial to evaluate the effectiveness, safety and tolerability of a new regimen which combines moxifloxacin, bedaqualine and pyrazinamide, plus a new agent, pretomanid (BPaMZ). The regimen is given for either four or six months.

Patients with drug-sensitive TB are randomised at a ratio of 1:1 to either four months of BPaMZ or to six months of standard first line TB treatment (HRZE). Patients with drug-resistant TB are enrolled and treated for six months of BPaMZ.

Type of study

Randomised trial

Who is funding the study?

The trial is funded by the Global Alliance for TB Drug Development.

When is it taking place?

The trial opened July 2018 and follow-up is ongoing.

Where is it taking place?

South Africa, Tanzania, Uganda, Georgia and Malaysia.

Who is included?

The trial aimed to enroll 300 patients with drug-sensitive TB and up to 150 patients with drug-resistant TB.