Linezolid Pharmacokinetics (PK) in Multi-Drug Resistant (MDR)/Extensively-Drug Resistant (XDR) Tuberculosis (TB)
Information source: Centers for Disease Control and Prevention
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multi-Drug Resistant Tuberculosis; Extensively Drug Resistant Tuberculosis
Intervention: Linezolid (Drug); Microcrystalline Methylcellulose - Placebo (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Centers for Disease Control and Prevention Official(s) and/or principal investigator(s): Nesri Padayatchi, MBChB, Principal Investigator, Affiliation: University of KwaZulu Marc Weiner, MD, Principal Investigator, Affiliation: The University of Texas at San Antonio
Summary
This is a one-period, double-blind, single-center pharmacokinetic study of linezolid in
patients with MDR or XDR tuberculosis treated with linezolid and an Optimized Background
Therapy (defined as treatment with > 4 drugs with activity against tuberculosis to which the
patient's isolate is believed to be sensitive by history or based on drug sensitivity
testing).
Clinical Details
Official title: Linezolid Pharmacokinetics and Pharmacodynamics in the Treatment of Multi-Drug Resistant and Extensively-Drug Resistant Tuberculosis
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Characterize linezolid pharmacokinetic parameters (AUC0-24 and linezolid time over MIC) in patients with MDR-TB and XDR-TB.
Secondary outcome: Assess the pharmacodynamic effects of linezolid AUC0-24 on tolerability (bone marrow toxicity, peripheral and ocular neuropathies) and safety during four months of treatment of tuberculosischaracterize the pharmacokinetics of ofloxacin and potentially other second line anti-tuberculous drugs utilized in the treatment of patients with MDR TB. Assess the pharmacodynamic effect of linezolid pharmacokinetic parameters ( on biomarkers of treatment activity. Biomarkers to be evaluated are time to detection in liquid culture, sputum culture conversion at two and four months of study treatment.
Detailed description:
This is a one-period, double-blind, single-center pharmacokinetic study of linezolid in
patients with MDR or XDR tuberculosis treated with linezolid and an Optimized Background
Therapy (defined as treatment with > 4 drugs with activity against tuberculosis to which the
patient's isolate is believed to be sensitive by history or based on drug sensitivity
testing).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Enrolled in the TBTC Study 30
- Provision of informed consent for the study
Exclusion Criteria:
- Severe anemia as defined by a hematocrit less than 25% (most recent value, measured
within 30 days of the PK study).
Locations and Contacts
King George V Hospital, Durban, KwaZulu Natal, South Africa
Additional Information
Starting date: April 2009
Last updated: August 15, 2012
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