NCT02454205View on ClinicalTrials.gov

An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

November 12, 2015

Primary Completion Date

December 31, 2020

Study Completion Date

August 30, 2021

Conditions
TuberculosisMultidrug Resistant TuberculosisExtensively-drug Resistant Tuberculosis
Interventions
DRUG

Linezolid

600mg Linezolid po daily, reduced to 300mg po daily if toxicity occurs.

DRUG

Bedaquiline

400mg po daily for 2 weeks, followed by 200mg three times per week .

DRUG

Levofloxacin

750mg (\<50kg) 1000mg (\>50kg)

DRUG

Pyrazinamide

1000-1750mg (40-50kg) 1750-2000mg (51-70kg) 2000-2500mg (71-90kg)

DRUG

Isoniazid

high dose Isoniazid 500mg (40-50kg) 750mg (51-70kg) 750-1000mg (71-90kg)

DRUG

Ethionamide

15mg/kg (max 900mg)

DRUG

Terizidone

750mg (40-70kg) 750-1000mg (71-90kg)

DRUG

Moxifloxacin

400mg po daily.

DRUG

Kanamycin

500-750mg (40-50kg) 1000mg (51-90kg) intramuscular daily during 6-8 month intensive phase.

Trial Locations (1)

7441

Brooklyn Chest Hospital, Cape Town

All Listed Sponsors
collaborator

University of Limpopo

OTHER

collaborator

Walter Sisulu University

OTHER

collaborator

University of Stellenbosch

OTHER

collaborator

University of Cape Town Lung Institute

OTHER

lead

University of Cape Town

OTHER

NCT02454205 - An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis | Biotech Hunter | Biotech Hunter