drugset / Trial / NCT02333799
A Phase 3 Trial Assessing Safety and Efficacy of B-Pa-L in Participants With DR-TB
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of bedaquiline plus PA-824 plus linezolid after 6 months of treatment (option for 9 months for participants who remain culture positive at month 4) in participants with either pulmonary extensively drug resistant tuberculosis (XDR-TB), treatment intolerant or non-responsive multi-drug resistant tuberculosis (MDR-TB).
Timeline
- Start
- 2015-03
- Primary completion
- 2019-01-14
- Completion
- 2020-08-03
Publications
- Solans BP, Imperial MZ, Olugbosi M, Savic RM. Analysis of Dynamic Efficacy Endpoints of the Nix-TB Trial. Clin Infect Dis. 2023 Jun 8;76(11):1903-1910. doi: 10.1093/cid/ciad051.
- Imperial MZ, Nedelman JR, Conradie F, Savic RM. Proposed Linezolid Dosing Strategies to Minimize Adverse Events for Treatment of Extensively Drug-Resistant Tuberculosis. Clin Infect Dis. 2022 May 30;74(10):1736-1747. doi: 10.1093/cid/ciab699.
- Conradie F, Diacon AH, Ngubane N, Howell P, Everitt D, Crook AM, Mendel CM, Egizi E, Moreira J, Timm J, McHugh TD, Wills GH, Bateson A, Hunt R, Van Niekerk C, Li M, Olugbosi M, Spigelman M; Nix-TB Trial Team. Treatment of Highly Drug-Resistant Pulmonary Tuberculosis. N Engl J Med. 2020 Mar 5;382(10):893-902. doi: 10.1056/NEJMoa1901814.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 200 mg | Oral |
| Subject | Linezolid | Other / unclassified | 300 mg | Oral |
| Subject | Linezolid | Other / unclassified | 600 mg | Oral |
| Subject | Linezolid | Other / unclassified | 1200 mg | Oral |
| Subject | Pretomanid | Small molecule | 200 mg | Oral |