drugset / Trial / NCT02454205
An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis
Phase 2/3
Completed
154 enrolled
University of Cape Town
University of Cape Town Lung Institute · collabUniversity of Limpopo · collabUniversity of Stellenbosch · collabWalter Sisulu University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims to evaluate the impact of a new injection-free six-to-nine month treatment regimen of linezolid, bedaquiline, levofloxacin, pyrazinamide (PZA) and ethionamide/high dose isoniazid (INH) compared to the conventional empiric injection-based regimen. The secondary aim is to determine if other treatment-related outcomes including adverse events, adherence to treatment, culture conversion, and cure/completion are significantly different in the intervention and conventional arms.
Timeline
- Start
- 2015-11-12
- Primary completion
- 2020-12-31
- Completion
- 2021-08-30
Publications
- Esmail A, Oelofse S, Lombard C, Perumal R, Mbuthini L, Goolam Mahomed A, Variava E, Black J, Oluboyo P, Gwentshu N, Ngam E, Ackerman T, Marais L, Mottay L, Meier S, Pooran A, Tomasicchio M, Te Riele J, Derendinger B, Ndjeka N, Maartens G, Warren R, Martinson N, Dheda K. An All-Oral 6-Month Regimen for Multidrug-Resistant Tuberculosis: A Multicenter, Randomized Controlled Clinical Trial (the NExT Study). Am J Respir Crit Care Med. 2022 May 15;205(10):1214-1227. doi: 10.1164/rccm.202107-1779OC.
- Wasserman S, Huo S, Ky K, Malig YN, Esmail A, Dheda K, Bacchetti P, Gerona R, Maartens G, Gandhi M, Metcalfe J. Correlation of Linezolid Hair Concentrations with Plasma Exposure in Patients with Drug-Resistant Tuberculosis. Antimicrob Agents Chemother. 2020 Feb 21;64(3):e02145-19. doi: 10.1128/AAC.02145-19. Print 2020 Feb 21. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 200 mg | Oral |
| Subject | Ethionamide | Small molecule | 15 mg/kg | Oral |
| Subject | Isoniazid | Small molecule | 500 mg | Oral |
| Subject | Isoniazid | Small molecule | 750 mg | Oral |
| Subject | Isoniazid | Small molecule | 1000 mg | Oral |
| Comparator | Kanamycin | Small molecule | 500 mg | Intramuscular |
| Comparator | Kanamycin | Small molecule | 750 mg | Intramuscular |
| Comparator | Kanamycin | Small molecule | 1000 mg | Intramuscular |
| Subject | Levofloxacin | Small molecule | 750 mg | Oral |
| Subject | Levofloxacin | Small molecule | 1000 mg | Oral |
| Subject | Linezolid | Other / unclassified | 600 mg | Oral |
| Comparator | Moxifloxacin | Small molecule | 400 mg | Oral |
| Subject | Pyrazinamide | Small molecule | 1000 mg | — |
| Subject | Pyrazinamide | Small molecule | 1750 mg | — |
| Subject | Pyrazinamide | Small molecule | 2000 mg | — |
| Subject | Pyrazinamide | Small molecule | 2500 mg | — |
| Subject | Terizidone | Small molecule | 750 mg | Oral |
| Subject | Terizidone | Small molecule | 1000 mg | Oral |