At a glance
ClinicalIndex Comparison Record- ✓Male, age 18 years or older
- ✓Body weight ≥45 kg
- ✓Positive molecular test for TB in sputum at screening or within 1 month prior to enrollment
- ✓TB diagnosed prior to or at screening, resistant to rifampicin and/or isoniazid, susceptible to fluoroquinolones by rapid sputum-based tests
- ✕Fluoroquinolone-resistant TB
- ✕History of male infertility or vasectomy
- ✕Unable to produce semen sample or evidence of azoospermia at screening
- ✕Erectile dysfunction that would prevent ejaculation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Pretomanid, Bedaquiline, and 2 other interventions for Tuberculosis, Pulmonary and 4 related conditions. Completed, enrolled 26 participants across 4 sites in 2 countries.
Detailed 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).
Study Details
Timeline
Interventions
pretomanid 200 mg (once daily) for 26 weeks (with meal)
bedaquiline 200 mg (once daily) for 8 weeks (with meal), then bedaquiline 100mg (once daily) for 18 weeks (with meal)
moxifloxacin 400 mg (once daily) for 26 weeks (with meal)
pyrazinamide 1500 mg (once daily) for 26 weeks (with meal)