Ultra-short bedaquiline-based regimen for drug-susceptible TB
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-11336952 · Data updated 2026-11-12
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.
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 | July 7, 2022 |
| Project end | December 31, 2027 |
| Funding year | 2026 |
| Award (this year) | $526,275 |
| NIH project number | 4U01AI170426-05 |
| Project ID | NIH-11336952 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults (21+ years) with smear-positive drug-susceptible TB, including those with HIV, who can participate at selected clinical research sites.
✕Less likely to help
Patients with drug-resistant TB or those unable to tolerate the study drug regimen may not benefit from this approach.
What this research studies
This trial tests a 12-week regimen of bedaquiline, clofazimine, pyrazinamide, and delamanid against standard 26-week therapy in adults with smear-positive DS-TB, including those living with HIV. The approach was guided by an AI-enabled platform to identify effective drug-dose combinations quickly. Participants will be followed for up to 86 weeks to monitor effectiveness and safety, with sites in Haiti and South Africa. The study seeks to determine if the shorter regimen can achieve faster culture conversion and relapse-free cure. If successful, this could offer a shorter, tolerable option for TB patients and reduce treatment burden.
Why it matters
Potential benefit: If successful, patients may benefit from a shorter, rifamycin-free treatment with potentially fewer drug interactions and a faster path to cure.
How similar studies have gone: Previous studies have used AI-guided regimens and shown promise in identifying effective drug combinations, with preclinical data supporting rapid relapse-free cure in models.
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 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 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.
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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.