The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB

PHASE3CompletedINTERVENTIONAL
Enrollment

588

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

May 13, 2022

Study Completion Date

May 2, 2023

Conditions
MDR-TB
Interventions
DRUG

Regimen A locally-used WHO-approved MDR-TB regimen (2011 guideline)

Drug: Locally-used WHO-approved MDR-TB regimen

DRUG

Moxifloxacin

Moxifloxacin is an 8-methoxy quinolone, and an anti-bacterial fluoroquinolone

DRUG

Clofazimine

Clofazimine, is an antileprosy and anti-bacterial agent. Its chemical name is 3-(p-chloroanilino)-10-(p-chlorophenyl)-2, 10-dihydro-2-isopropyliminophenazine.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

Prothionamide

Prothionamide has a bacteriostatic action.

DRUG

Kanamycin

Kanamycin is a bactericidal antibiotic from the group of aminoglycosides.

DRUG

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.

DRUG

Bedaquiline

Bedaquiline is a novel diarylquinoline antibiotic with bactericidal activity

Trial Locations (13)

Unknown

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

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medical Research Council

OTHER_GOV

collaborator

Institute of Tropical Medicine, Belgium

OTHER

collaborator

Liverpool School of Tropical Medicine

OTHER

collaborator

Rede TB

INDUSTRY

lead

IUATLD, Inc

OTHER