PRESCIENT: Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible TB

Study Director
Serena Koenig, MD
Start Date
11 / 2023
Trial Phase
Phase II
Trial Status
Current Enrollment
Target Enrollment

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.

Experimental Arms: 

  • BCZD - 12 weeks
    • Bedaquiline 200 mg for 12 weeks + pyrazinamide 1000 - 2000 mg (according to weight) for 12 weeks + clofazimine 300 mg for 2 weeks, followed by 100 mg for 10 weeks + delamanid 200 mg for 12 weeks, all given once daily.
  • Standard HRZE 6-month Treatment