Shorter all-oral treatment for multidrug-resistant tuberculosis
DRAMATIC Phase 2 Duration Randomized MDR-TB Treatment Trial
Seeing if a shorter, all-oral drug combination can cure people with multidrug-resistant tuberculosis while causing fewer side effects.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of California, San Francisco NIH-funded |
| Lab location | 1 site (San Francisco, United States) |
| Project ID | NIH-11393204 on NIH RePORTER |
What this research studies
If you have multidrug-resistant tuberculosis (MDR-TB), this trial could randomize you to one of four treatment lengths of an all-oral drug combination including bedaquiline, delamanid, levofloxacin, and a limited 8-week course of linezolid. The regimen avoids pyrazinamide and injectable drugs and limits linezolid to the early treatment period to reduce nerve damage risk. The trial is partially blinded, takes place at multiple clinical centers, and uses a novel "duration-randomization" design that compares different fixed treatment lengths together to find the shortest effective course. Animal data support the drug combination, and the study follows participants for safety and cure outcomes.
Who could benefit from this research
Good fit: Adults with laboratory-confirmed multidrug-resistant pulmonary tuberculosis who meet the study's medical and safety criteria would be the intended participants.
Not a fit: People whose TB is resistant to the study drugs or who cannot safely take the medications are unlikely to be helped by this trial.
Why it matters
Potential benefit: If successful, the regimen could cure MDR-TB with a shorter, all-oral course that has less toxicity than current long treatments.
How similar studies have performed: Some component drugs and animal studies have shown promise, but shortening fixed treatment durations in humans is not yet proven and the duration-randomization design is a new approach.
Where this research is happening
San Francisco, United States
- University of California, San Francisco — San Francisco, United States (Active)
Researchers
- Principal investigator: Nahid, Payam — University of California, San Francisco
- Study coordinator: Nahid, Payam
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.