A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Dr… (NCT04179500) | Clinical Trial Compass
CompletedPhase 2
A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis
Georgia, South Africa26 participantsStarted 2021-09-16
Plain-language 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).
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Understands study procedures and voluntarily provides written informed consent prior to the start of any study-specific procedures.
✓. Male gender 18 years or over
✓. Body weight (in light clothing and no shoes) ≥ 45kg.
✓. A positive molecular test for tuberculosis in sputum either at screening or within one month prior to enrolment.
✓. Disease Characteristics:
✓. A chest x-ray, within 26 weeks prior to or at the screening visit, which in the opinion of the Investigator is compatible with pulmonary TB
Exclusion criteria
✕. Resistant to fluoroquinolones by rapid molecular test
. Known erectile dysfunction that would prevent ejaculation.
✕. Historical or active disease process of the male reproductive tract that would compromise sperm production. e.g. tuberculous epididymitis.
✕. History of any illness that, in the opinion of the Investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
✕. For HIV infected participants any of the following: