NCT04062201View on ClinicalTrials.gov

Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care

PHASE3CompletedINTERVENTIONAL
Enrollment

402

Participants

Timeline

Start Date

August 22, 2019

Primary Completion Date

April 15, 2024

Study Completion Date

April 15, 2024

Conditions
TuberculosisPre-XDR-TBExtensively Drug-Resistant TuberculosisMulti Drug Resistant TuberculosisRifampicin Resistant Tuberculosis
Interventions
DRUG

Bedaquiline Oral Tablet

Weight Group 16 - 29.9kg: 200mg daily for two weeks; followed by 100mg three times weekly for weeks 3 - 24 Weight Group: 30 - \>50kg: 400mg once daily for 14 days followed by 200mg three times weekly for weeks 3 - 24

DRUG

Linezolid Oral Tablet

Weight Group 16 - 23kg: 180 - 210mg (crush 1 tab and mix in 10ml water, administer 3-3.5ml. Discard rest) Weight Group 23.1 - 29.9kg: 300mg daily Weight Group 30 - 33.9kg: 450mg daily Weight Group 34 - \>50kg: 600mg daily

DRUG

Delamanid in Oral Dosage Form

Weight Group 16 - 23kg: 25mg twice daily for 24 weeks Weight Group 23.1 - 33.9kg: 50mg twice daily for 24 weeks Weight Group 34 - \>50kg: 100mg twice daily for 8 weeks followed by 200 mg daily for 16 weeks

DRUG

Clofazimine Oral Product

Weight Group 16 - 23kg: 100mg three times a week or 50mg daily Weight Group 23.1 - \>50kg: 100mg daily

DRUG

Levofloxacin Oral Tablet

Weight Group 16 - 23kg: 375 - 500mg daily Weight Group 23.1 - 33.9kg: 500mg once daily Weight Group 34 - 50kg: 750mg daily Weight Group \>50kg:1000mg daily

DRUG

Isoniazid Oral Product

Weight Group 16 - 23kg: 300mg daily Weight Group 23.1 - 50kg: 400mg daily Weight Group \>50kg: 600mg daily

DRUG

Ethambutol Oral Product

Weight Group 16 - 23kg: 400mg daily Weight Group 23.1 - 29.9kg: 600mg daily Weight Group 30 - 50kg: 800mg daily Weight Group \>50kg: 1200mg daily

DRUG

Pyrazinamide Oral Product

Weight Group 16 - 23kg: 750mg daily Weight Group 23.1 - 29.9kg: 1000mg daily Weight Group 30 - 33.9kg: 1250mg daily Weight Group 34 - 50kg: 1500mg daily Weight Group \>50kg: 2000mg daily

DRUG

Linezolid Oral Tablet

Weight Group 16 - 23kg: 180 - 210mg (crush 1 tab and mix in 10ml water, administer 3-3.5ml. Discard rest) Weight Group 23.1 - 29.9kg: 300mg daily Weight Group 30 - 33.9kg: 450mg daily Weight Group 34 - \>50kg: 600mg daily

DRUG

Clofazimine Oral Product

Weight Group 16 - 23kg: 100mg three times a week or 50mg daily Weight Group 23.1 - \>50kg: 100mg daily

DRUG

Levofloxacin Oral Tablet

Weight Group 16 - 23kg: 375 - 500mg daily Weight Group 23.1 - 33.9kg: 500mg once daily Weight Group 34 - 50kg: 750mg daily Weight Group \>50kg:1000mg daily

Trial Locations (2)

4015

King DinuZulu Hospital Complex, Durban

6003

Jose Pearson TB Hospital, Port Elizabeth

All Listed Sponsors
collaborator

Regents of the University of California

OTHER

collaborator

University of Cape Town

OTHER

collaborator

Perinatal HIV Research Unit of the University of the Witswatersrand

OTHER

lead

Wits Health Consortium (Pty) Ltd

OTHER

NCT04062201 - Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care | Biotech Hunter | Biotech Hunter