drugset / Trial / NCT03086486
Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis
RandomizedParallel-groupTriple-blindTreatment
Summary
To evaluate the efficacy, safety and tolerability of various doses and durations of linezolid plus bedaquiline and pretomanid after 26 weeks of treatment in participants with either pulmonary XDR-TB, pre-XDR-TB, or treatment intolerant or non-responsive MDR-TB.
Timeline
- Start
- 2017-11-21
- Primary completion
- 2021-02-15
- Completion
- 2022-02-08
Publications
- Bruning-Barry R, Ambroso JL, Yang X, Hickman D, Harkins AM, Noble M, Paris M, Foraida S, Sun E, Beumont M. Safety evaluation of pretomanid, an anti-tuberculosis drug, for the treatment of pregnant and lactating women. Antimicrob Agents Chemother. 2026 Jul 10:e0034326. doi: 10.1128/aac.00343-26. Online ahead of print.
- Conradie F, Bagdasaryan TR, Borisov S, Howell P, Mikiashvili L, Ngubane N, Samoilova A, Skornykova S, Tudor E, Variava E, Yablonskiy P, Everitt D, Wills GH, Sun E, Olugbosi M, Egizi E, Li M, Holsta A, Timm J, Bateson A, Crook AM, Fabiane SM, Hunt R, McHugh TD, Tweed CD, Foraida S, Mendel CM, Spigelman M; ZeNix Trial Team. Bedaquiline-Pretomanid-Linezolid Regimens for Drug-Resistant Tuberculosis. N Engl J Med. 2022 Sep 1;387(9):810-823. doi: 10.1056/NEJMoa2119430.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 100 mg | — |
| Subject | Linezolid | Other / unclassified | 600 mg | — |
| Subject | Linezolid | Other / unclassified | 1200 mg | — |
| Subject | Pretomanid | Small molecule | 200 mg | — |