Personalized linezolid dosing for rifampin-resistant tuberculosis
Therapeutic drug monitoring for linezolid in the treatment of rifampin-resistant tuberculosis: a pragmatic randomized controlled trial
['FUNDING_R01'] · ALBERT EINSTEIN COLLEGE OF MEDICINE · NIH-11458322
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
| Phase | ['FUNDING_R01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | ALBERT EINSTEIN COLLEGE OF MEDICINE (nih funded) |
| Locations | 1 site (BRONX, UNITED STATES) |
| Trial ID | NIH-11458322 on ClinicalTrials.gov |
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.
Who could benefit from this research
Good fit: Adults with rifampin-resistant (RR) tuberculosis who are receiving or starting linezolid, including people living with HIV, are the ideal candidates.
Not a fit: Children, people not taking linezolid, or patients treated outside participating clinics are unlikely to be eligible or benefit from participating.
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 performed: 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
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.
Conditions: Acquired Immune Deficiency Syndrome Virus, Acquired Immunodeficiency Syndrome Virus