Ultra-short, rifamycin-free 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
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 ID | NIH-11385223 on NIH RePORTER |
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.
Who could benefit from this research
Good fit: Adults with confirmed drug-susceptible pulmonary tuberculosis, including people on antiretroviral therapy, are the intended participants.
Not a fit: 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.
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 performed: 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
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.