Trial

"endTB" - Evaluating Newly Approved Drugs for Multidrug-resistant TB (MSF ERB-1555)

Study Director
Francis Varaine, MD Médecins Sans Frontières France
Start Date
12 / 2016
Trial Phase
Phase III
Trial Status
enrolling
Current Enrollment
82 (April 2018)
Target Enrollment
750
Overview

Compound Associations: 

endTB Clinical Trial a Phase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of five new, all-oral, shortened regimens for multidrug-resistant tuberculosis (MDR-TB). endTB (expand new drug markets for TB) aims to find shorter, less toxic & more effective treatments for MDR-TB, using the first two drugs developed in 50 years: bedaquiline and delamanid. Covering 15 countries, the project is a partnership between Partners in Health, Medecins Sans Frontieres, Interactive Research & Development, and financial partner UNITAID UNITAID. The endTB project is expected to enroll an estimated 2600 MDR-TB patients on treatment with the new TB drugs and 750 patients will take part in a clinical trial across six countries: Georgia, Kazakhstan, Kyrgyzstan, Lesotho, Peru and South Africa.

Primary Outcome Measures: Week 73 Efficacy [ Time Frame: Week 73 after randomization ]

Proportion of participants with favorable outcome at week 73. A participant's outcome will be classified as favorable at week 73 if the outcome is not classified as unfavorable, and one of the following is true:

  • The last two culture results are negative. These two cultures must be taken from sputum samples collected on separate visits, the latest between weeks 65 and 73;
  • The last culture result (from a sputum sample collected between weeks 65 and 73) is negative; and either there is no other post-baseline culture result or the penultimate culture result is positive due to laboratory cross contamination; and bacteriological, radiological and clinical evolution is favorable;
  • There is no culture result from a sputum sample collected between weeks 65 and 73 or the result of that culture is positive due to laboratory cross contamination; and the most recent culture result is negative; and bacteriological, radiological and clinical evolution is favorable.

endTB regimen 1 (BeLiMoZ)

endTB regimen 2 (BeLiCLeZ)

endTB regimen 3 (BeDeLiLeZ)

endTB regimen 4 (DeLiCLeZ)

endTB regimen 5 (DeCMoZ)