Overview

Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)

Status:
Active, not recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Medecins Sans Frontieres, Netherlands
Collaborators:
Drugs for Neglected Diseases
eResearch Technology, Inc.
Global Alliance for TB Drug Development
London School of Hygiene and Tropical Medicine
Ministry of Health, Republic of Uzbekistan
Ministry of Health, Swaziland
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
Treatments:
Bedaquiline
Clofazimine
Diarylquinolines
Fluoroquinolones
Linezolid
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination