drugset / Trial / NCT02589782
Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)
Phase 2/3
Completed
552 enrolled
Medecins Sans Frontieres, Netherlands
Drugs for Neglected Diseases · collabGlobal Alliance for TB Drug Development · collabLondon School of Hygiene and Tropical Medicine · collabMinistry of Health, Republic of Uzbekistan · collabMinistry of Public Health, Republic of Belarus · collabRutgers, The State University of New Jersey · collabSwiss Tropical & Public Health Institute · collabTHINK TB & HIV Investigative Network · collabUniversity College, London · collabUniversity of California, San Francisco · collabUniversity of Liverpool · collabWits Health Consortium (Pty) Ltd · collabWorld Health Organization · collabeResearch Technology, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
TB PRACTECAL is a multi-centre, open label, multi-arm, randomised, controlled, phase II-III trial; evaluating short treatment regimens containing bedaquiline and pretomanid in combination with existing and re-purposed anti-TB drugs for the treatment of biologically confirmed pulmonary multi drug-resistant TB (MDR-TB).
Timeline
- Start
- 2017-01
- Primary completion
- 2022-08-05
- Completion
- 2022-08-05
Publications
- Motta I, Cusinato M, Ludman AJ, Lachenal N, Dodd M, Soe M, Abdrasuliev T, Usmanova R, Butabekov I, Nikolaevna TZ, Liverko I, Parpieva N, Moodliar R, Solodovnikova V, Kazounis E, Nyang'wa B-T, Fielding KL, Berry C. How much should we still worry about QTc prolongation in rifampicin-resistant tuberculosis? ECG findings from TB-PRACTECAL clinical trial. Antimicrob Agents Chemother. 2024 Jul 9;68(7):e0053624. doi: 10.1128/aac.00536-24. Epub 2024 Jun 6.
- Nyang'wa BT, Berry C, Kazounis E, Motta I, Parpieva N, Tigay Z, Moodliar R, Dodd M, Solodovnikova V, Liverko I, Rajaram S, Rassool M, McHugh T, Spigelman M, Moore DA, Ritmeijer K, du Cros P, Fielding K; TB-PRACTECAL team. Short oral regimens for pulmonary rifampicin-resistant tuberculosis (TB-PRACTECAL): an open-label, randomised, controlled, phase 2B-3, multi-arm, multicentre, non-inferiority trial. Lancet Respir Med. 2024 Feb;12(2):117-128. doi: 10.1016/S2213-2600(23)00389-2. Epub 2023 Nov 16.
- Nyang'wa BT, Berry C, Kazounis E, Motta I, Parpieva N, Tigay Z, Solodovnikova V, Liverko I, Moodliar R, Dodd M, Ngubane N, Rassool M, McHugh TD, Spigelman M, Moore DAJ, Ritmeijer K, du Cros P, Fielding K; TB-PRACTECAL Study Collaborators. A 24-Week, All-Oral Regimen for Rifampin-Resistant Tuberculosis. N Engl J Med. 2022 Dec 22;387(25):2331-2343. doi: 10.1056/NEJMoa2117166.
- Berry C, du Cros P, Fielding K, Gajewski S, Kazounis E, McHugh TD, Merle C, Motta I, Moore DAJ, Nyang'wa BT. TB-PRACTECAL: study protocol for a randomised, controlled, open-label, phase II-III trial to evaluate the safety and efficacy of regimens containing bedaquiline and pretomanid for the treatment of adult patients with pulmonary multidrug-resistant tuberculosis. Trials. 2022 Jun 13;23(1):484. doi: 10.1186/s13063-022-06331-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 200 mg | Oral |
| Subject | Clofazimine | Small molecule | 50 mg | Oral |
| Subject | Clofazimine | Small molecule | 100 mg | Oral |
| Subject | Linezolid | Other / unclassified | 300 mg | Oral |
| Subject | Moxifloxacin | Small molecule | 400 mg | Oral |
| Subject | Pretomanid | Small molecule | 200 mg | Oral |