Shortening and simplifying treatment for hard to treat forms of TB
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.
ZeNix is a phase 3 partially-blinded, randomised trial assessing the safety and efficacy of various doses and treatment durations of linezolid plus bedaquiline and pretomanid (BPaL) in participants with pulmonary infection of either extensively drug-resistant tuberculosis (XDR-TB), pre-XDR-TB or treatment intolerant or non-responsive multidrug resistant tuberculosis (MDR-TB).
Type of study
Who is funding the study?
Global Alliance for TB Drug Development
When is it taking place?
Recruitment started in November 2017 and results are expected in 2022
Where is it taking place?
The trial is currently recruiting in South Africa, Georgia, Moldova and Russia
Who is included?
180 patients with XDR, pre-XDR or MDR treatment intolerant or non-responsive TB