Ultra-short rifamycin-free TB treatment using bedaquiline, clofazimine, pyrazinamide and delamanid
PRESCIENT: A phase IIc, open-label, randomized controlled trial of ultra-short course bedaquiline, clofazimine, pyrazinamide and delamanid versus standard therapy for drug-susceptible tuberculosis
This trial sees if a four-drug, rifamycin-free regimen can cure drug-susceptible tuberculosis much faster than standard therapy for adults, including people with HIV.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Brigham and Women's Hospital NIH-funded |
| Lab location | 1 site (Boston, United States) |
| Project ID | NIH-11373879 on NIH RePORTER |
What this research studies
You would be randomly assigned to take either the new four-drug combination (bedaquiline, clofazimine, pyrazinamide and delamanid) given for a very short course or the usual TB treatment, and everyone will be followed with regular clinic visits, sputum tests, and safety checks. The drug combo was selected using an AI-guided method after very promising results in mouse models showing relapse-free cure in weeks. The trial is open-label, so you and the care team will know which regimen you receive, and researchers will watch for cure, side effects, and any TB coming back after treatment. If you join, you can expect frequent monitoring early on and scheduled follow-up visits to confirm lasting cure and safety.
Who could benefit from this research
Good fit: Adults with confirmed drug-susceptible pulmonary tuberculosis who meet the trial's health and eligibility criteria, including some people on antiretroviral therapy, are the intended participants.
Not a fit: People with drug-resistant TB, children, pregnant people, or those with medical conditions that raise risk from these drugs (for example certain heart rhythm problems) are unlikely to benefit from this trial regimen.
Why it matters
Potential benefit: If successful, this could shorten TB treatment from months to weeks and reduce harmful interactions with HIV medicines, making treatment simpler and safer.
How similar studies have performed: Preclinical mouse studies showed very rapid, relapse-free cures with this drug combination, but this four-drug, ultra-short rifamycin-free approach is novel in humans and has limited clinical data so far.
Where this research is happening
Boston, United States
- Brigham and Women's Hospital — Boston, United States (Active)
Researchers
- Principal investigator: Koenig, Serena Patricia — Brigham and Women's Hospital
- Study coordinator: Koenig, Serena Patricia
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.