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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
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)
National Center for Tuberculosis and Lung Diseases
Tbilisi, Georgia
CHRU, Sizwe Tropical Diseases Hospital
Johannesburg, South Africa
Isango Lethemba TB Research Unit Empilweni TB Hospital
Port Elizabeth, South Africa
The Aurum Institute: Rustenburg Clinical Research Centre
Rustenburg, South Africa
Change Form Baseline Total Sperm Count
Change from baseline in total sperm number at 26 weeks of therapy. Total sperm count is calculated by multiplying the sperm cell concentration by the ejaculate volume.
Time frame: Week 26
Change From Baseline in Total Sperm Count at 12 Weeks
Change from baseline in total sperm number at 12 weeks of therapy. Total sperm count is calculated by multiplying the sperm cell concentration by the ejaculate volume.
Time frame: Baseline to Week 12
Change From Baseline Total Sperm Count at 44 Weeks
Change from baseline in total sperm number at 44 weeks (18 months post treatment completion). Total sperm count is calculated by multiplying the sperm cell concentration by the ejaculate volume.
Time frame: Baseline through 44 weeks
Luteinizing Hormone (LH)
(LH) at baseline, 26, 44, and 78 weeks.
Time frame: Baseline to Week 78
FSH
FSH at baseline, weeks 26, 44 and 78
Time frame: Baseline to week 78
Testosterone
testosterone level at baseline, 26, 44 and 78 weeks.
Time frame: Baseline to 78 weeks
Inhibin B
inhibin B at baseline, weeks 26, 44 and 78
Time frame: Baseline to 78 weeks
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