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 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 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.
ZeNix is a phase III, partially-blinded, randomised trial assessing the safety and effectiveness 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).
ZeNix results have been published and are available to read in the New England Journal of Medicine.
Type of study
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 in November 2017 and the last participant was randomised in December 2019.
Where is it taking place?
South Africa, Georgia, Moldova, and Russia.
Who is included?
The trial enrolled 181 patients with XDR, pre-XDR, or MDR treatment intolerant or non-responsive TB