Monitoring linezolid blood levels to reduce treatment interruptions in rifampin-resistant TB

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pragmatic, open-label, randomized two-arm trial comparing therapeutic drug monitoring (TDM) of linezolid versus standard care in adults treated for rifampin-resistant tuberculosis. Eligible participants must have started a linezolid-containing RR-TB regimen within 14 days and are followed through the roughly six-month course of therapy. The intervention uses trough plasma concentrations to guide dose adjustments aimed at reducing linezolid-associated myelosuppression and peripheral neuropathy that frequently force treatment interruptions. Both HIV-positive and HIV-negative adults are included, and outcomes focus on premature discontinuation of linezolid and safety measures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult male or female patient \> 18 years of age
* Microbiological confirmation of rifampicin-resistant tuberculosis (e.g., phenotypic or genotypic drug susceptibility testing, GeneXpert MTB/RIF™). Participants may have resistance to additional medications as well - i.e., MDR and XDR TB - but must have resistance to at least rifampin
* Initiated on a rifampicin-resistant tuberculosis (RR-TB) treatment regimen containing linezolid, no more than 14 days prior to randomization
* HIV status is known and confirmed

  * Both HIV-positive and HIV-negative individuals are eligible
  * If an individual reports unknown HIV status, they must consent to HIV testing at time of enrollment to confirm status. If they decline to be tested, they are not eligible for the study

Exclusion Criteria:

* Severe medical condition with expected death in the next 7 days
* Pregnant at time of screening
* Initial linezolid dose \< 600mg daily
* Severe form of extrapulmonary TB (i.e., meningitis, pericarditis, or osteomyelitis)
* Unlikely to follow-up at Nkqubela Hospital based on location of residence

Where it's running

• Nkqubela TB Specialist Hospital
  East London, Eastern Cape, South Africa Recruiting

Study contacts

• Principal investigator: James CM Brust, MD — Albert Einstein College of Medicine
• Study coordinator: James CM Brust, MD
• Email: james.brust@einsteinmed.edu
• Phone: 718-920-6482

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.