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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 tuberculosis

characterize 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

Page last updated: August 23, 2015

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