Personalized linezolid dosing for rifampin-resistant tuberculosis
Official title: Therapeutic drug monitoring for linezolid in the treatment of rifampin-resistant tuberculosis: a pragmatic randomized controlled trial
Funded at Albert Einstein College of Medicine · NIH-11458322 · Data updated 2026-11-12
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.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Albert Einstein College of Medicine NIH-funded |
| Lab location | 1 site (Bronx, United States) |
| Project start | December 1, 2024 |
| Project end | November 30, 2029 |
| Funding year | 2026 |
| Award (this year) | $229,905 |
| NIH project number | 3R01AI184416-02S1 |
| Project ID | NIH-11458322 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with rifampin-resistant (RR) tuberculosis who are receiving or starting linezolid, including people living with HIV, are the ideal candidates.
✕Less likely to help
Children, people not taking linezolid, or patients treated outside participating clinics are unlikely to be eligible or benefit from participating.
What this research studies
You would be randomly assigned to receive routine linezolid dosing or to have your dose guided by blood tests that measure the drug level. Doctors will check linezolid trough concentrations and change dose or schedule for people with high levels that raise risk of bone marrow suppression or nerve damage. Study visits will include regular blood tests, safety exams, and tracking of treatment response and side effects over the course of therapy. The goal is to keep the drug strong enough to cure TB while cutting down on toxicities that often force treatment to stop.
Why it matters
Potential benefit: If successful, blood-guided dosing could lower the chance of serious side effects and reduce treatment interruptions, improving cure rates for rifampin-resistant TB patients.
How similar studies have gone: Observational studies (including prior work by this group) link higher linezolid blood levels to toxicity, but randomized trials of therapeutic drug monitoring for linezolid in RR-TB are limited, so this approach is promising but not yet proven.
Where this research is happening
-
Albert Einstein College of Medicine
Bronx, United States Active
Researchers
- Principal investigator: Brust, James C M — Albert Einstein College of Medicine
- Study coordinator: Brust, James C M
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
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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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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.