Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial

CompletedOBSERVATIONAL
Enrollment

137

Participants

Timeline

Start Date

September 1, 2019

Primary Completion Date

May 10, 2022

Study Completion Date

May 10, 2022

Conditions
Multidrug Resistant Tuberculosis
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 a 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 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

Directly observed therapy (DOT)

Standard therapy

Trial Locations (6)

3650

THINK Clinical Trial Unit, Hillcrest, Durban

Unknown

Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital, Minsk

Doris Goodwin Hospital, Pietermaritzburg

Helen Jospeh Hospital, Johannesburg

Republican TB Hospital No. 2, Nukus

Sh Alimov Republican Specialised Scientific-Practical Medical Centre for Phthysiology and Pulmonology Hospital, Tashkent

All Listed Sponsors
collaborator

University of Sussex

OTHER

collaborator

London School of Hygiene and Tropical Medicine

OTHER

collaborator

THINK TB & HIV Investigative Network

NETWORK

collaborator

Wits Health Consortium (Pty) Ltd

OTHER

collaborator

Ministry of Public Health, Republic of Belarus

OTHER_GOV

collaborator

Ministry of Health, Republic of Uzbekistan

OTHER_GOV

lead

Medecins Sans Frontieres, Netherlands

OTHER

NCT03942354 - Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial | Biotech Hunter | Biotech Hunter