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

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.

Conditions

• Tuberculosis, Pulmonary
• HIV

Interventions

DRUG

Bedaquiline

Daily therapy for 12 weeks

DRUG

Clofazimine

Daily therapy for 12 weeks

DRUG

Pyrazinamide

Daily therapy for 12 weeks

DRUG

Delamanid

Daily therapy for 12 weeks

DRUG

Rifampin

Daily therapy for 26 weeks

DRUG

Isoniazid

Daily therapy for 26 weeks

DRUG

Ethambutol

Daily therapy for 8 weeks

DRUG

Pyrazinamide

Daily therapy for 8 weeks

Sponsors & Collaborators

• University of Cape Town

  collaborator OTHER

• Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

  collaborator OTHER

• University of Stellenbosch

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• Harvard School of Public Health (HSPH)

  collaborator OTHER

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Serena Koenig, MD, MPH · Brigham and Women's Hospital

• Sean Wasserman, MBChB, PhD · University of Cape Town

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-24

Primary Completion

2025-06-12

Completion

2027-01-31

Countries

• Haiti
• South Africa

Study Locations