Assessing the Safety and Efficacy of Bedaquiline Plus PA-824 Plus Linezolid in Subjects With Drug Resistant Pulmonary Tuberculosis
Shortening and simplifying treatment for hard to treat forms of 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.
Nix-TB is a single-arm trial assessing the safety and effectiveness 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).
The results of the trial 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?
Recruitment opened in April 2015 and closed in November 2017.
Where is it taking place?
Three sites in South Africa.
Who is included?
The trial aimed to enroll 109 patients with XDR, pre-XDR or MDR treatment intolerant or non-responsive TB