Ultra-short, rifamycin-free treatment for drug-susceptible tuberculosis
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-11385223 · Data updated 2026-11-12
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.
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) | $406,451 |
| NIH project number | 3U01AI170426-04S2 |
| Project ID | NIH-11385223 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with confirmed drug-susceptible pulmonary tuberculosis, including people on antiretroviral therapy, are the intended participants.
✕Less likely to help
People with drug-resistant TB, children, pregnant people, or those unable to attend frequent clinic visits are unlikely to be eligible or benefit from this regimen.
What this research studies
Adults with drug-susceptible TB will be randomly assigned to either an about-8-week combination of bedaquiline, clofazimine, pyrazinamide and delamanid or the standard longer TB regimen. The study is open-label, so participants and clinicians will know which treatment is given, and researchers will monitor participants during and after therapy for cure, side effects, and relapse. The drug combination was selected using an AI platform after strong results in mouse models, and the trial aims to see if the same shorter, rifamycin-free approach works safely in people, especially where HIV medicines interact with standard TB drugs. Follow-up includes clinic visits, lab tests, and careful monitoring for adverse events and TB recurrence.
Why it matters
Potential benefit: If successful, this could cut TB treatment from months down to weeks and reduce harmful interactions with HIV therapy, making treatment shorter and easier to complete.
How similar studies have gone: The individual drugs have shown activity against TB and have been used in other regimens, but this specific ultra-short, rifamycin-free combination is novel and has so far shown success mainly in animal studies rather than in large human trials.
Where this research is happening
-
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 TB treatment using bedaquiline, clofazimine, pyrazinamide and delamanid
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.
-
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.