Trial

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

Study Director
Lorenzo Guglielmetti, MD, PhD; Médecins Sans Frontières France; and Carole Mitnick, PhD; Harvard Medical School
Start Date
12 / 2016
Trial Phase
Phase III
Trial Status
all patients enrolled
Current Enrollment
754 (October 2021)
Target Enrollment
750
Overview

The endTB clinical trial is a Phase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of five new, all-oral, shortened 9-month regimens for fluoroquinolone-susceptible multidrug-resistant tuberculosis (MDR-TB). Participants were assigned to experimental and control arms according to Bayesian outcome-adaptive randomization. The endTB randomized controlled clinical trial enrolled 754 participants across twelve sites in seven countries (Georgia, India, Kazakhstan, Lesotho, Pakistan, Peru, and South Africa). Primary outcome results are expected in the third quarter of 2023.

endTB experimental regimen 1: Bdq-Lzd-Mfx-Z

endTB experimental regimen 2: Bdq-Cfz-Lfx-Lzd-Z

endTB experimental regimen 3: Bdq-Dlm-Lfx-Lzd-Z

endTB experimental regimen 4: Cfz-Dlm-Lfx-Lzd-Z

endTB experimental regimen 5: Dlm-Cfz-Mfx-Z

For more information on this trial, visit the project website at http://www.endtb.org/clinical-trial