Overview

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

Status:
Not yet recruiting

Trial end date:
2026-01-01

Target enrollment:

Participant gender:

Summary

The PRESCIENT trial is a Phase IIc, open-label, randomized trial that will compare an 8-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.

Phase:

Phase 2

Details

Lead Sponsor:

Brigham and Women's Hospital

Collaborators:

Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
Harvard School of Public Health (HSPH)
University of California, Los Angeles
University of Cape Town
University of Stellenbosch

Treatments:

Bedaquiline
Clofazimine
Ethambutol
Isoniazid
Pyrazinamide
Rifampin