73
Participants
Start Date
October 20, 2020
Primary Completion Date
August 25, 2022
Study Completion Date
August 25, 2022
Bedaquiline
Bedaquiline is a diarylquinoline class antimicrobial which blocks the proton pump for ATP synthase of mycobacteria. This in turn blocks the ATP production required for cellular energy production and leading to cell death.
Pretomanid
Pretomanid is an nitroimidazole class antimicrobial which interferes with cell wall biosynthesis in mycobacteria. It may have other mechanisms of action as well in non-replicating mycobacteria.
Moxifloxacin
Moxifloxacin is an 8-methoxyquinolone class antimicrobial that is a potent inhibitor of DNA gyrase and topoisomerase IV in bacteria
Linezolid
Linezolid, an oxazolidinone class antimicrobial which works by inhibiting ribosomal protein synthesis. It is approved for Gram-positive bacterial infections, and is increasingly being used for drug resistant TB disease.
Clofazimine
Clofazimine (Cfz) is a lipophilic riminophenazine licensed for treatment of leprosy. Its mechanism(s) of action remains unclear, but existing evidence suggests production of reactive oxygen species within Mycobacterium tuberculosis is one mechanism.
Standard Drugs
Locally accepted standard of care which is consistent with the WHO recommendations for the treatment of M/XDR-TB.
Helen Joseph Hospital, Johannesburg
THINK Clinical Trial Unit, Hillcrest, Durban
King DinuZulu Hospital, Durban
Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital, Minsk
Doris Goodwin Hospital, Pietermaritzburg
Republican TB Hospital No. 2, Nukus
Sh Alimov Republican Specialised Scientific-Practical Medical Centre for Phthysiology and Pulmonology Hospital, Tashkent
London School of Hygiene and Tropical Medicine
OTHER
Ministry of Health, Republic of Uzbekistan
OTHER_GOV
Ministry of Public Health, Republic of Belarus
OTHER_GOV
THINK TB & HIV Investigative Network
NETWORK
University of Liverpool
OTHER
Wits Health Consortium (Pty) Ltd
OTHER
Medecins Sans Frontieres, Netherlands
OTHER