588
Participants
Start Date
March 31, 2016
Primary Completion Date
May 13, 2022
Study Completion Date
May 2, 2023
Regimen A locally-used WHO-approved MDR-TB regimen (2011 guideline)
Drug: Locally-used WHO-approved MDR-TB regimen
Moxifloxacin
Moxifloxacin is an 8-methoxy quinolone, and an anti-bacterial fluoroquinolone
Clofazimine
Clofazimine, is an antileprosy and anti-bacterial agent. Its chemical name is 3-(p-chloroanilino)-10-(p-chlorophenyl)-2, 10-dihydro-2-isopropyliminophenazine.
Ethambutol
Ethambutol is a bacteriostatic that acts against virtually all strains of Mycobacterium tuberculosis and M. bovis and is also active against other mycobacteria such as M. Kansasii.
Pyrazinamide
Pyrazinamide is bactericidal against intracellular mycobacterium tuberculosis. It is a prodrug that is converted into its active form, pyrazinoic acid, by a mycobacterial enzyme, pyrazinamidase, as well as through hepatic metabolism.
Isoniazid
Isoniazid is a bactericidal in vitro and in vivo against actively dividing tubercle bacilli. Its primary action is to inhibit the synthesis of long-chain mycolic acids, which are unique constituents of mycobacterial cell wall.
Prothionamide
Prothionamide has a bacteriostatic action.
Kanamycin
Kanamycin is a bactericidal antibiotic from the group of aminoglycosides.
Levofloxacin
Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class that acts on the DNA-DNA-gyrase complex and topoisomerase IV. It is the S (-) enantiomer of the racemic active substance ofloxacin.
Bedaquiline
Bedaquiline is a novel diarylquinoline antibiotic with bactericidal activity
Armauer Hanssen Research Institute, Addis Ababa
St. Peter's Tuberculosis Specializes Hospital, Addis Ababa
JSC National Center for Tuberculosis and Lung Diseases, Tbilisi
BJ Medical College Civil Hospital, Ahmedabad
The National Institute for Research in Tuberculosis, Chennai
Rajan Babu Institute for Pulmonary Medicine and Tuberculosis, New Delhi
Institute of Phthisiopneumology 'Chiril Draganiuc', Chisinau
National Centre for Communicable Diseases, Ulaanbaatar
King Dinizulu Hospital, Durban
Helen Joseph Hospital, Johannesburg
Doris Goodwin Hospital, Pietermaritzburg
Empilweni TB Hospital, Port Elizabeth
Makerere University (Mulago Referral Hospital), Kampala
Collaborators (1)
Medical Research Council
OTHER_GOV
Institute of Tropical Medicine, Belgium
OTHER
Liverpool School of Tropical Medicine
OTHER
Rede TB
INDUSTRY
IUATLD, Inc
OTHER