Using blood tests to personalize linezolid dosing for rifampin-resistant TB
Therapeutic drug monitoring for linezolid in the treatment of rifampin-resistant tuberculosis: a pragmatic randomized controlled trial
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.
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 ID | NIH-11238488 on NIH RePORTER |
What this research studies
If you have rifampin-resistant TB and are prescribed linezolid, the trial will randomly assign you to routine care or to regular blood tests that measure linezolid levels with dose adjustments to keep levels in a safer range. Doctors will follow participants throughout treatment to watch for common linezolid side effects like low blood counts and nerve damage and to record whether the infection is cured. The approach is designed to be used in regular clinic settings and aims to reduce treatment interruptions that can lead to worse outcomes or more drug resistance. The study is run from Albert Einstein College of Medicine and includes adults, with attention to people living with HIV who face higher risks.
Who could benefit from this research
Good fit: Adults with rifampin-resistant tuberculosis who are being treated with linezolid, including people living with HIV, are the most likely candidates for this work.
Not a fit: People not taking linezolid (for example those with drug-sensitive TB), children, or anyone unable to have routine blood tests are unlikely to be eligible or benefit from this trial.
Why it matters
Potential benefit: If successful, this could reduce serious side effects and treatment interruptions while improving cure rates by tailoring linezolid doses to each person.
How similar studies have performed: Observational studies have linked high linezolid levels to toxicity and suggest monitoring may help, but large randomized trials of therapeutic drug monitoring for linezolid are limited.
Where this research is happening
Bronx, United States
- 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
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.