PanACEA - STEP2C -01

PHASE2RecruitingINTERVENTIONAL
Enrollment

390

Participants

Timeline

Start Date

April 14, 2023

Primary Completion Date

October 31, 2027

Study Completion Date

December 30, 2027

Conditions
Pulmonary TuberculosisOther Specified Pulmonary Tuberculosis
Interventions
DRUG

BTZ-043

BTZ-043 1000mg once daily in arms 4 and 6.

DRUG

Rifampicin

Rifampicin will be dosed in a fixed high-dose (2100 mg for arms 1 and 2) or a weight-banded regular dose (10 mg/kg) in arm 3, 5 and 7.

DRUG

Isoniazid

Isoniazid will be dosed at fixed dose of 300mg in arms 1 and 2, and regular dose of 5 mg/kg in arm 3 and 7.

DRUG

Pyrazinamide

Pyrazinamide will be dosed in a fixed regular dose in arm 1 (1600 mg), a weight banded high dose in arm 2 (2000/2400 mg) or a weight-banded regular dose (25 mg/kg) in arm 3, 5 and 7.

DRUG

Moxifloxacin

Moxifloxacin will be dosed at 600 mg orally once daily in arms 1-2.

DRUG

Alpibectir (GSK3729098)

Alpibectir 45 mg OD plus Ethionamide 500 mg OD combined with rifampicin pyrazinamide and ethambutol at standard weight-banded doses in arm 5.

DRUG

Ganfeborole (GSK3036656)

Ganfeborole 20 mg OD in arm 6

DRUG

Delpazolid (LCB01-0371)

Delpazolid 1200mg OD in arm 6

DRUG

Pretomanid (Pa)

Pretomanid 20mg OD in arm 6.

DRUG

Ethambutol (E)

Ethambutol 20mg/Kg OD in arm 3, 5 and 7

DRUG

Ethionamide

Ethionamide 500mg OD in arm 5.

Trial Locations (10)

6003

NOT_YET_RECRUITING

Isango Lethemba TB Research Unit. Clinical HIV Research Unit (CHRU), Wits Health Consortium., Port Elizabeth

7500

RECRUITING

TASK Applied Sciences Clinical Research Centre, Cape Town

7700

NOT_YET_RECRUITING

University of Cape Town Lung Institute, Cape Town

Unknown

COMPLETED

Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné

RECRUITING

Kamuzu College of Health Sciences (formerly College of Medicine), Blantyre

RECRUITING

Instituto Nacional de Saúde (INS), Maputo

RECRUITING

National Institute for Medical Research (NIMR-MMRC), Mbeya

RECRUITING

Ifakara Health Institute (IHI), Bagamoyo

RECRUITING

Kilimanjaro Clinical Research Institute (KCRI), Moshi

RECRUITING

Makerere University Lung Institute Limited, Kampala

All Listed Sponsors
collaborator

Radboud University Medical Center

OTHER

collaborator

University of California, San Francisco

OTHER

collaborator

University College, London

OTHER

collaborator

GlaxoSmithKline

INDUSTRY

collaborator

LigaChem Biosciences, Inc.

INDUSTRY

lead

Michael Hoelscher

OTHER

NCT05807399 - PanACEA - STEP2C -01 | Biotech Hunter | Biotech Hunter