NCT04179500View on ClinicalTrials.gov

A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis

PHASE2CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

September 16, 2021

Primary Completion Date

June 19, 2023

Study Completion Date

July 17, 2024

Conditions
Tuberculosis, PulmonaryTuberculosis, Multidrug-ResistantTuberculosis, MDRTuberculosisDrug-Resistant Tuberculosis
Interventions
DRUG

Pretomanid

pretomanid 200 mg (once daily) for 26 weeks (with meal)

DRUG

Bedaquiline

bedaquiline 200 mg (once daily) for 8 weeks (with meal), then bedaquiline 100mg (once daily) for 18 weeks (with meal)

DRUG

moxifloxacin

moxifloxacin 400 mg (once daily) for 26 weeks (with meal)

DRUG

pyrazinamide

pyrazinamide 1500 mg (once daily) for 26 weeks (with meal)

Trial Locations (4)

Unknown

National Center for Tuberculosis and Lung Diseases, Tbilisi

CHRU, Sizwe Tropical Diseases Hospital, Johannesburg

Isango Lethemba TB Research Unit Empilweni TB Hospital, Port Elizabeth

The Aurum Institute: Rustenburg Clinical Research Centre, Rustenburg

All Listed Sponsors
lead

Global Alliance for TB Drug Development

OTHER

NCT04179500 - A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis | Biotech Hunter | Biotech Hunter