Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)
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
Sponsor: Drugs for Neglected Diseases
Listed as NCT02589782, this PHASE2/PHASE3 trial focuses on Extensively Drug-Resistant Tuberculosis and Tuberculosis, Multidrug-Resistant and remains completed. Sponsored by Drugs for Neglected Diseases, it has been updated 12 times since 2017, reflecting substantial change activity. This study is part of the global effort to build evidence for infectious disease interventions.
Status Flow
Change History
12 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE2/PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2/PHASE3
Phase: PHASE2_PHASE3 → PHASE2/PHASE3
-
Jun 2024 — Jul 2024 [monthly]
Completed PHASE2_PHASE3
Status: Unknown Status → Completed
-
Jun 2023 — Jun 2024 [monthly]
Unknown Status PHASE2_PHASE3
Status: Active Not Recruiting → Unknown Status
-
Jun 2021 — Jun 2023 [monthly]
Active Not Recruiting PHASE2_PHASE3
Status: Recruiting → Active Not Recruiting
▶ Show 7 earlier versions
-
Jan 2021 — Jun 2021 [monthly]
Recruiting PHASE2_PHASE3
-
Nov 2020 — Jan 2021 [monthly]
Recruiting PHASE2_PHASE3
-
Aug 2019 — Nov 2020 [monthly]
Recruiting PHASE2_PHASE3
-
Jun 2018 — Aug 2019 [monthly]
Recruiting PHASE2_PHASE3
-
Apr 2018 — Jun 2018 [monthly]
Recruiting PHASE2_PHASE3
-
Feb 2017 — Apr 2018 [monthly]
Recruiting PHASE2_PHASE3
Status: Not Yet Recruiting → Recruiting
-
Jan 2017 — Feb 2017 [monthly]
Not Yet Recruiting PHASE2_PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Drugs for Neglected Diseases
- Global Alliance for TB Drug Development
- London School of Hygiene and Tropical Medicine
- Medecins Sans Frontieres, Netherlands
- Ministry of Health, Republic of Uzbekistan
- Ministry of Public Health, Republic of Belarus
- Rutgers, The State University of New Jersey
- Swiss Tropical & Public Health Institute
- THINK TB & HIV Investigative Network
- University College, London
- University of California, San Francisco
- University of Liverpool
- Wits Health Consortium (Pty) Ltd
- World Health Organization
- eResearch Technology, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .