Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)
NCT02589782 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 552
Last updated 2024-05-01
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).
Conditions
- Tuberculosis, Multidrug-Resistant
- Extensively Drug-Resistant Tuberculosis
- Tuberculosis, Pulmonary
Interventions
- DRUG
-
Bedaquiline
- DRUG
-
Pretomanid
- DRUG
-
Moxifloxacin
- DRUG
-
Linezolid
- DRUG
-
Clofazimine
- DRUG
-
Locally accepted standard of care which is consistent with the WHO recommendations for the treatment of M/XDR-TB.
Sponsors & Collaborators
-
London School of Hygiene and Tropical Medicine
collaborator OTHER -
Global Alliance for TB Drug Development
collaborator OTHER -
University College, London
collaborator OTHER -
Drugs for Neglected Diseases
collaborator OTHER -
Swiss Tropical & Public Health Institute
collaborator OTHER -
eResearch Technology, Inc.
collaborator INDUSTRY -
Ministry of Health, Republic of Uzbekistan
collaborator OTHER_GOV - collaborator OTHER
-
Ministry of Public Health, Republic of Belarus
collaborator OTHER_GOV -
THINK TB & HIV Investigative Network
collaborator NETWORK -
University of Liverpool
collaborator OTHER -
Wits Health Consortium (Pty) Ltd
collaborator OTHER -
Rutgers, The State University of New Jersey
collaborator OTHER -
University of California, San Francisco
collaborator OTHER -
Medecins Sans Frontieres, Netherlands
lead OTHER
Principal Investigators
-
Bern-Thomas Nyang'wa, MD · Medecins Sans Frontieres, Netherlands
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-01-31
- Primary Completion
- 2022-08-05
- Completion
- 2022-08-05
Countries
- Belarus
- South Africa
- Uzbekistan
Study Locations
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