Tuberculosis (TB) is a globally spread disease which is caused by the bacteria Mycobacterium tuberculosis. The current standard of care consists of a combination therapy of different antibiotics. However, multidrug-resistant (MDR) M. tuberculosis strains emerge strongly, complicating efforts to control the global TB epidemic.
Providing Evidence for Shorter Treatment Regimens
Over the past few years, the use of new drugs such as Delamanid and Bedaquiline have dramatically changed MDR-TB treatment possibilities. Shorter MDR-TB treatment regimens using these drugs in combination with existing drugs were integrated in the WHO Guidelines for treatment; however, the evidence base for some combinations remains low. Therefore, a need for high quality evidence to demonstrate safety and efficacy of particular combinations remains.
TB-Practecal is a phase II/III randomized control trial that evaluates the safety and efficacy of combinations of new (Bedaquiline, Pretomanid) and existing TB drugs (Linezolid, Moxifloxacin, Clofazimine) in a 6-month treatment regimen. The aim is find a regimen with minimal side effects that will improve outcomes in patients and provide quality evidence for shorter MDR-TB treatment regimens.
The trial began in January 2017 with the study site Nukus (Karakalpakstan), Uzbekistan, and later included sites in Tashkent, Uzbekistan, Belarus and South Africa. Stage 1 (Phase II) of the study was completed in December 2019, showing that all three regimens were safe and effective. Stage 2 (Phase III) of the trial began in the fall of 2020 and evaluates the most promising regimen versus the current standard of care. Estimated enrolment of 630 patients is planned.
The trial is run and sponsored by the international medical humanitarian organisation Médecins Sans Frontières/Doctors Without Borders (MSF) and is supported by the London School of Hygiene & Tropical Medicine, as well as other leaders in medical research. The Clinical Operations Unit from Swiss TPH is responsible for the monitoring of the trial.