drugset / Trial / NCT04179500
A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2021-09-16
- Primary completion
- 2023-06-19
- Completion
- 2024-07-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pretomanid | Small molecule | 200 mg | — |
| Background | Bedaquiline | Small molecule | 100 mg | — |
| Background | Moxifloxacin | Small molecule | 400 mg | — |
| Background | Pyrazinamide | Small molecule | 1500 mg | — |