NIH-funded research R01 grant

Using blood tests to personalize linezolid dosing for rifampin-resistant TB

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-11238488 · Data updated 2026-11-12

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.

More Tuberculosis research and trials

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionAlbert Einstein College of Medicine
NIH-funded
Lab location1 site (Bronx, United States)
Project startDecember 1, 2024
Project endNovember 30, 2029
Funding year2026
Award (this year)$464,199
NIH project number5R01AI184416-02
Project IDNIH-11238488 on NIH RePORTER

Who could benefit from this research

Could help

Adults with rifampin-resistant tuberculosis who are being treated with linezolid, including people living with HIV, are the most likely candidates for this work.

Less likely to help

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.

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.

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 gone: 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

  • 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.

  • Shorter, rifamycin-free TB treatment using BCZD for drug-susceptible TB

    A 12-week, AI-informed drug combination (bedaquiline, clofazimine, pyrazinamide, and delamanid) is being tested against the standard 26-week therapy for adults with drug-susceptible TB to see if it can cure faster with fewer side effects.

    NIH research Brigham and Women's Hospital · Boston, United States · NIH-11563787

  • Shorter TB treatment using four drugs for drug-susceptible TB

    A 12-week, AI-informed drug regimen (bedaquiline, clofazimine, pyrazinamide, delamanid) is being tested against standard therapy for drug-susceptible TB to see if it works faster and safely across adults in Haiti and South Africa.

    NIH research Brigham and Women's Hospital · Boston, United States · NIH-11563786

  • Personalized linezolid dosing for rifampin-resistant tuberculosis

    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.

    NIH research Albert Einstein College of Medicine · Bronx, United States · NIH-11458322

  • 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.

    NIH research Brigham and Women's Hospital · Boston, United States · NIH-11385223

  • 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.

    NIH research Brigham and Women's Hospital · Boston, United States · NIH-11373879

  • 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.

    NIH research Brigham and Women's Hospital · Boston, United States · NIH-11336952

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.