Overview

A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant (DR-TB) Pulmonary TB Volunteers (PaSEM)

Status:
Recruiting

Trial end date:
2023-04-01

Target enrollment:

Participant gender:

Summary

Pretomanid is being used in an antimicrobial combination regimen(s) to treat patients with pulmonary tuberculosis. 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).

Phase:

Phase 2

Details

Lead Sponsor:

Global Alliance for TB Drug Development

Treatments:

Bedaquiline
Moxifloxacin
Pyrazinamide