drugset / Trial / NCT05556746
Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible TB
Phase 2
Active not recruiting
94 enrolled
Brigham and Women's Hospital
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic · collabHarvard School of Public Health (HSPH) · collabUniversity of California, Los Angeles · collabUniversity of Cape Town · collabUniversity of Stellenbosch · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The PRESCIENT trial is a Phase IIc, open-label, randomized trial that will compare a 12-week regimen of bedaquiline (BDQ), clofazimine (CFZ), pyrazinamide (PZA), and delamanid (DLM) with standard treatment for drug-susceptible pulmonary tuberculosis. Eligible participants will be randomized in a 1:1 ratio to BDQ, CFZ, PZA, and DLM (BCZD) or standard anti-TB therapy. Participants in the experimental arm with evidence of poor clinical response at the end of therapy will be re-treated with standard TB therapy. The primary analysis is a superiority efficacy comparison of time to liquid culture conversion through 8 weeks in the experimental (BCZD) arm vs. the standard therapy arm. The other key secondary outcome is safety.
Timeline
- Start
- 2023-11-24
- Primary completion
- 2025-06-12
- Completion
- 2027-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 200 mg | — |
| Subject | Clofazimine | Small molecule | 100 mg | — |
| Subject | Delamanid | Small molecule | 200 mg | — |
| Comparator | Ethambutol | Small molecule | — | — |
| Comparator | Isoniazid | Small molecule | — | — |
| Comparator | Pyrazinamide | Small molecule | 1000 mg | — |
| Comparator | Pyrazinamide | Small molecule | 2000 mg | — |
| Comparator | Rifampicin | Small molecule | — | — |