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 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.

Nix-TB is a single-arm trial assessing the safety and efficacy 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

Non-randomised trial

Who is funding the study?

Global Alliance for TB Drug Development

When is it taking place?

Recruitment took place between April 2015 and November 2017. Primary results are expected in 2019

Where is it taking place?

The trial recruited from 3 sites in South Africa

Who is included?

109 patients with XDR, pre-XDR or MDR treatment intolerant or non-responsive TB