]

BPaMZ/SEM

Partners: University of St. Andrews

Background:

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-week antimicrobial combination regimen consisting of bedaquiline (B) plus pretomanid (Pa) plus moxifloxacin (M) and pyrazinamide (Z) (BPaMZ).

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 (DR) pulmonary TB.

The secondary objective of the study is to evaluate the TB treatment efficacy, safety and tolerability after 26 weeks of active treatment for TB and follow up until 45 weeks after start of the above described treatment regimen in participants with Drug-resistant (DR) pulmonary TB.

Phase 2

Trial Components

Regimens