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. Randomization will be stratified by presence of lung cavitation and HIV status. Medications will be given daily in fixed dose combinations at standard weight-based doses. Adherence will be supported through automated reminders and monitored remotely in real time with Wisepill electronic adherence monitoring devices or with directly observed treatment. Participants in the experimental arm with evidence of poor clinical response 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. Estimated primary completion date is in 2025-06, while the estimated study completion is in 2027-01.
Experimental Regimen:
Bedaquiline: 200 mg/day for 12 weeks
Clofazimine: 300 mg/day for 2 weeks, followed by 100 mg/day for 10 weeks
Pyrazinamide: 1000 - 2000 mg/day (according to weight) for 12 weeks
Delamanid: 200 mg/day for 12 weeks
Registry Link