Therapeutic Drug Monitoring for Linezolid in the Treatment of Rifampin-resistant Tuberculosis

Not Applicable

Not yet recruiting

• Conditions: Rifampin-resistant Tuberculosis; Drug-resistant Tuberculosis

• Registration Number: NCT06590428
• Lead Sponsor: Albert Einstein College of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-9-9
• Last Update Posted: 23 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Inclusion Criteria:<br><br> - Adult male or female patient > 18 years of age<br><br> - Microbiological confirmation of rifampicin-resistant tuberculosis (e.g., phenotypic<br> drug susceptibility testing, GeneXpert MTB/RIF™). Participants may have resistance<br> to additional medications as well - i.e., MDR and XDR TB - but must have resistance<br> to at least rifampin<br><br> - Initiated on a RR-TB treatment regimen containing linezolid, no more than 14 days<br> prior to enrollment<br><br> - HIV status is known<br><br> - Both HIV-positive and HIV-negative individuals are eligible<br><br> - If an individual reports unknown HIV results, they must consent to HIV testing<br> at time of enrollment to confirm status. If they decline to be tested, they are<br> not eligible for the study<br><br> - If an individual declines to share his or her HIV status, they are not eligible<br> for the study. Patients reporting unknown HIV status will be required to have<br> had confirmatory testing within 6 months of study screening<br><br>Exclusion Criteria:<br><br> - Current unstable or uncontrolled major medical comorbidity that would interfere with<br> subject's ability to participate in the study<br><br> - Pregnant at time of screening<br><br> - Initial linezolid dose < 600mg daily

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Discontinuation of Linezolid or non-TDM guided dose reduction

Secondary Outcome Measures

Name	Time	Method
Evidence of Linezolid Toxicity;Unsuccessful final Tuberculosis (TB) end-of-treatment outcome;Emergence of new phenotypic resistance to Linezolid