Ultra-short rifamycin-free TB treatment using bedaquiline, clofazimine, pyrazinamide and delamanid
Official title: 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
Funded at Brigham and Women's Hospital · NIH-11373879 · Data updated 2026-11-12
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 start | May 1, 2025 |
| Project end | April 30, 2027 |
| Funding year | 2025 |
| Award (this year) | $398,334 |
| NIH project number | 3U01AI170426-04S1 |
| Project ID | NIH-11373879 on NIH RePORTER |
Who could benefit from this research
✓Could help
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.
✕Less likely to help
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.
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.
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 gone: 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
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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
Related research
Other NIH-funded projects on the same topics.
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Shorter, rifamycin-free TB treatment using BCZD for drug-susceptible TB
A 12-week, AI-informed drug combination (bedaquiline, clofazimine, pyrazinamide, and delamanid) is being tested against the standard 26-week therapy for adults with drug-susceptible TB to see if it can cure faster with fewer side effects.
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Shorter TB treatment using four drugs for drug-susceptible TB
A 12-week, AI-informed drug regimen (bedaquiline, clofazimine, pyrazinamide, delamanid) is being tested against standard therapy for drug-susceptible TB to see if it works faster and safely across adults in Haiti and South Africa.
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Personalized linezolid dosing for rifampin-resistant tuberculosis
This work compares standard linezolid dosing to dosing adjusted using blood tests to help adults with rifampin-resistant tuberculosis, including people living with HIV, get effective treatment while reducing harmful side effects.
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Ultra-short, rifamycin-free treatment for drug-susceptible tuberculosis
This compares a four-drug, rifamycin-free, very short TB treatment to the usual longer therapy for adults with drug-susceptible tuberculosis, including people taking HIV medicines.
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Ultra-short bedaquiline-based regimen for drug-susceptible TB
A 12-week, AI-guided drug combination trial tests a shorter, rifamycin-free treatment for adults with drug-susceptible TB, aiming to cure faster with fewer drug interactions.
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Using blood tests to personalize linezolid dosing for rifampin-resistant TB
This project tests whether checking linezolid blood levels and adjusting doses helps adults with rifampin-resistant tuberculosis, including people with HIV, get safer and more effective treatment.
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.