Short-course Regimens for the Treatment of Pulmonary Tuberculosis

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

288

Participants

Timeline

Start Date

November 21, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Tuberculosis, PulmonaryTuberculosis Infection
Interventions
DRUG

Rifabutin

Rifabutin (Rb) is added to the bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) regimen for first 8 weeks and continued for next 9 weeks with bedaquiline (B or BDQ) and moxifloxacin (M)

DRUG

Delamanid

Delamanid (D or DLM) is added to the bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) regimen for first 8 weeks and continued for next 9 weeks with bedaquiline (B or BDQ) and moxifloxacin (M)

DRUG

Bedaquiline

Bedaquiline is part of interventional arms with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ).

DRUG

Moxifloxacin

Moxifloxacin is part of interventional arms with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ).

DRUG

Pyrazinamide

Pyrazinamide is part of interventional arms with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ). Pyrazinamide is part of control regimen (HRZE).

DRUG

Isoniazid

Isoniazid is part of control regimen (HRZE).

DRUG

Rifampin

Rifampin is part of control regimen (HRZE).

DRUG

Ethambutol

Ethambutol is part of control regimen (HRZE).

Trial Locations (8)

7700

TBTC Site 09 University of Cape Town Lung Institute (Pty) Ltd, Mowbray

70000

TBTC Site 76 CAB-V. Can Tho Province, Vietnam - Thot Not District TB Unit, Can Tho

98104

TBTC Site 26 Seattle & King County TB Control Program, Seattle

Unknown

McGill University Health Centre, Montreal

Vancouver, British Columbia Centre for Disease Control, Vancouver

TBTC Site 30 Uganda-Case Western Reserve Research Collaboration, Kampala

HT 6124

TBTC Site 67 GHESKIO centers IMIS, Port-au-Prince

HT6110

TBTC Site 45 Les Centres Gheskio (INLR), Port-au-Prince

All Listed Sponsors
collaborator

Tuberculosis Trials Consortium

NETWORK

lead

Centers for Disease Control and Prevention

FED

NCT05766267 - Short-course Regimens for the Treatment of Pulmonary Tuberculosis | Biotech Hunter | Biotech Hunter