NCT04179500

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

An Open-Label Phase 2 Trial to Evaluate the Male Reproductive Safety of a 6-Month Combination Treatment for Pulmonary Tuberculosis (TB) of Bedaquiline Plus Pretomanid Plus Moxifloxacin Plus Pyrazinamide (BPaMZ) in Adult Male Participants With Drug Resistant Pulmonary TB

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Global Alliance for TB Drug Development · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pretomanid is being used in an antimicrobial combination regimen(s) to treat patients with pulmonary tuberculosis (TB). The primary purpose of the Male Reproductive Safety - "BPaMZ/SEM"- clinical study is to evaluate the potential effect of pretomanid on human testicular function whilst being used in a 26 weeks antimicrobial combination regimen consisting of bedaquiline (B) plus pretomanid (Pa) plus moxifloxacin (M) and pyrazinamide (Z) (BPaMZ).

Detailed description

The primary objective of this study is to assess the male reproductive safety of pretomanid in the regimen (BPaMZ) of bedaquiline 200mg (200mg daily for 8 weeks then 100 mg daily for 18 weeks), together with pretomanid 200 mg (1x daily) + moxifloxacin 400 mg (1x daily) + pyrazinamide 1500 mg (1 x daily) for 26 weeks in participants with drug-resistant pulmonary tuberculosis (DR-TB). The secondary objective of the study is to evaluate the tuberculosis (TB) treatment efficacy, safety and tolerability after 26 weeks of active treatment for TB and follow up until 52 weeks after end of the above-described treatment regimen in participants with DR-TB.

Conditions

• Tuberculosis, Pulmonary
• Tuberculosis, Multidrug-Resistant
• Tuberculosis, MDR
• Tuberculosis
• Drug-Resistant Tuberculosis

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2021-09-16
• Primary completion: 2023-06-19
• Completion: 2024-07-17
• First posted: 2019-11-27
• Last updated: 2025-01-17
• Results posted: 2024-09-19

Locations

4 sites across 2 countries: Georgia, South Africa

Regulatory

• FDA-regulated drug study