drugset / Trial / NCT03237182
The Individualized M(X) Drug-resistant TB Treatment Strategy Study
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized controlled clinical trial comparing treatment success of a gene-derived individualized drug-resistant Tuberculosis regimen to a standard Tuberculosis regimen based on South African National Tuberculosis guidelines.
Timeline
- Start
- 2017-06-14
- Primary completion
- 2022-12-19
- Completion
- 2022-12-19
Outcome
Outcome not reported
Stopped: “WHO 2022 guidelines for DR-TB treatment are set to change. These guidelines recommend the use of an all-oral short course BPAL regimen.Therefore ongoing implementation of the study is considered futile.”
Publications
- Background Musser JM. Antimicrobial agent resistance in mycobacteria: molecular genetic insights. Clin Microbiol Rev. 1995 Oct;8(4):496-514. doi: 10.1128/CMR.8.4.496.
- Background Outhred AC, Jelfs P, Suliman B, Hill-Cawthorne GA, Crawford AB, Marais BJ, Sintchenko V. Added value of whole-genome sequencing for management of highly drug-resistant TB. J Antimicrob Chemother. 2015 Apr;70(4):1198-202. doi: 10.1093/jac/dku508. Epub 2014 Dec 9.
- Maseko TG, Ngubane S, Letsoalo M, Rambaran S, Archary D, Samsunder N, Perumal R, Chinappa S, Padayatchi N, Naidoo K, Sivro A. Higher plasma interleukin - 6 levels are associated with lung cavitation in drug-resistant tuberculosis. BMC Immunol. 2023 Aug 31;24(1):26. doi: 10.1186/s12865-023-00563-2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amikacin | Small molecule | — | — |
| Subject | Azithromycin | Small molecule | — | — |
| Subject | Bedaquiline | Small molecule | — | — |
| Subject | Capreomycin | Protein / enzyme biologic | — | — |
| Subject | Clarithromycin | Small molecule | — | — |
| Subject | Clofazimine | Small molecule | — | — |
| Subject | Cycloserine | Small molecule | — | — |
| Subject | Ethambutol | Small molecule | — | — |
| Subject | Ethionamide | Small molecule | — | — |
| Subject | Gatifloxacin | Small molecule | — | — |
| Subject | Isoniazid | Small molecule | — | — |
| Subject | Kanamycin | Small molecule | — | — |
| Subject | Levofloxacin | Small molecule | — | — |
| Subject | Linezolid | Other / unclassified | — | — |
| Subject | Meropenem | Small molecule | — | — |
| Subject | Moxifloxacin | Small molecule | — | — |
| Subject | Ofloxacin | Small molecule | — | — |
| Subject | Pretomanid | Small molecule | — | — |
| Subject | Protionamide | Small molecule | — | — |
| Subject | Pyrazinamide | Small molecule | — | — |
| Subject | Rifabutin | Small molecule | — | — |
| Subject | Rifampicin | Small molecule | — | — |
| Subject | Sutezolid | Small molecule | — | — |
| Subject | Terizidone | Small molecule | — | — |
| Subject | amithiozone | Small molecule | — | — |
| Subject | amoxicillin/clavulanate | Unknown | — | — |
| Subject | delaminid | Unknown | — | — |
| Subject | imipenem/cilastatin | Unknown | — | — |
| Subject | para-aminosalicylic acid | Unknown | — | — |
| Subject | streptomycin | Other / unclassified | — | — |