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.
New Treatment Regimens are Urgent
There is an urgent need to enlarge treatment programs and, in addition, to develop new anti-tuberculosis agents. The latter is required due to the poor efficacy of current treatment regimens. Furthermore, treatment of MDR-TB is expensive and has difficulties with implementation in many settings leading to only around 20% of MDR-TB patients being on treatment. Thus, it is urgent to develop an improved treatment regimen which is efficacious and safe and that can be implemented quickly and on a broad scale.
Two Promising Candidates
Bedaquiline and pretomanid are new anti-tuberculosis agents. They affect novel targets in the tuberculosis bacilli and present promising new options to treat MDR-TB. This phase II/III study will evaluate safety and efficacy of novel combinations of new (bedaquline, pretomanid) and existing TB drugs (linezolid, moxifloxacin, clofazimine) in a 6-month treatment regimen. The aim is to improve currently very poor outcomes and shorten treatment of MDR-TB.
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. A Swiss TPH team from the Clinical Operations Unit is responsible for the monitoring of the trial.
The first trial site of TB PRACTECAL is based at the MSF supported hospital in Karakalpakstan, in North West Uzbekistan. Other sites will be in Belarus and South Africa.