Trial

Safety and Efficacy of Various Doses and Treatment Durations of Linezolid Plus Bedaquiline and Pretomanid in Participants With Pulmonary TB, XDR-TB, Pre- XDR-TB or Non-responsive/Intolerant MDR-TB (ZeNix)

Study Director
Dan Everitt
Start Date
2 / 2018
Trial Phase
Phase III
Trial Status
enrolling
Current Enrollment
25 (as of May 2018)
Target Enrollment
180
Overview

A phase 3, multi-center, partially-blinded, randomized clinical trial in four parallel treatment groups. Bedaquiline and pretomanid treatment will not be blinded. Linezolid treatment dose and duration will be double-blinded.

Participants will have a screening period of up to 9 days and will be randomized to receive one of the 4 active treatment arms. Participants will be randomized to one of the four regimens in a 1:1:1:1 ratio, using an interactive web response system (IWRS) which will utilize a dynamic randomization system using minimization with a random element to allocate participants evenly across the arms by HIV status and type of TB.

Each participant will receive 26 weeks of treatment. If participant's week 16 sample remains culture positive, Investigator may consider extending current treatment to 39 weeks, in consultation with the Sponsor Medical Monitor

Participants will be followed for 78 weeks after end of treatment.