Ultra-short, rifamycin-free four-drug treatment for drug-susceptible tuberculosis
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
Compares an ultra-short, rifamycin‑free four-drug regimen (bedaquiline, clofazimine, pyrazinamide, delamanid) to standard treatment for adults with drug-susceptible tuberculosis, including people on HIV medicines.
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-11086615 on NIH RePORTER |
What this research studies
If you join this randomized, open-label trial you would be assigned to either an experimental short-course four-drug regimen or the current standard TB treatment and followed over time for cure and relapse. The drug combination was picked using an artificial-intelligence platform and showed very fast, relapse-free cures in animal studies. Doctors will monitor symptoms, side effects, and test sputum and other samples to see how quickly the infection clears. The trial is designed to find out whether a rifamycin-free option can shorten treatment and avoid drug interactions with antiretroviral therapy used by people with HIV.
Who could benefit from this research
Good fit: Adults (21 years and older) with confirmed drug-susceptible pulmonary tuberculosis, including people living with HIV who are on antiretroviral therapy, would be the intended participants.
Not a fit: People with drug-resistant TB, children, pregnant people, or those with medical exclusions such as significant heart rhythm problems or other contraindications to the study drugs may not be eligible or benefit from this trial.
Why it matters
Potential benefit: If successful, this could greatly shorten TB treatment courses and reduce problematic interactions with HIV medications.
How similar studies have performed: Bedaquiline-containing regimens and other novel TB combinations have shown benefit in prior clinical work and the specific four-drug combo achieved rapid, relapse-free cures in animal models, but this exact ultra-short rifamycin-free regimen is new in human trials.
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.