Economic Evaluation of New MDR TB Regimens

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

October 20, 2020

Primary Completion Date

August 25, 2022

Study Completion Date

August 25, 2022

Conditions
Multi-drug Resistant TuberculosisExtensively Drug-Resistant TuberculosisPulmonary Tuberculoses
Interventions
DRUG

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.

DRUG

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.

DRUG

Moxifloxacin

Moxifloxacin is an 8-methoxyquinolone class antimicrobial that is a potent inhibitor of DNA gyrase and topoisomerase IV in bacteria

DRUG

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.

DRUG

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.

DRUG

Standard Drugs

Locally accepted standard of care which is consistent with the WHO recommendations for the treatment of M/XDR-TB.

Trial Locations (7)

2092

Helen Joseph Hospital, Johannesburg

3650

THINK Clinical Trial Unit, Hillcrest, Durban

4091

King DinuZulu Hospital, Durban

Unknown

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

All Listed Sponsors
collaborator

London School of Hygiene and Tropical Medicine

OTHER

collaborator

Ministry of Health, Republic of Uzbekistan

OTHER_GOV

collaborator

Ministry of Public Health, Republic of Belarus

OTHER_GOV

collaborator

THINK TB & HIV Investigative Network

NETWORK

collaborator

University of Liverpool

OTHER

collaborator

Wits Health Consortium (Pty) Ltd

OTHER

lead

Medecins Sans Frontieres, Netherlands

OTHER

NCT04207112 - Economic Evaluation of New MDR TB Regimens | Biotech Hunter | Biotech Hunter