A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant (DR-TB) Pulmonary TB Volunteers (PaSEM)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- 24
Summary
- Conditions
- Drug-Resistant Tuberculosis
- Tuberculosis
- Tuberculosis, MDR
- Tuberculosis, Multidrug Resistant
- Tuberculosis, Pulmonary
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Phase 2 single arm multi-center, open-label clinical trial in DR-TB participants. Participants will receive bedaquiline 200 mg once daily for 8 weeks then 100 mg once daily for 18 weeks together with pretomanid 200 mg + moxifloxacin 400 mg + pyrazinamide 1500 mg once daily (BPaMZ) for 26 weeks. Participants will be followed for 18 weeks after end of treatmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
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 da...
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.
Tracking Information
- NCT #
- NCT04179500
- Collaborators
- Not Provided
- Investigators
- Study Chair: Paul Bruinenberg, MD, MBA Global Alliance for TB Drug Development
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