At a glance
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Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5
In Brief
A Phase 4 clinical trial evaluating Telavancin and Pharmacokinetic Blood Sampling for End-Stage Renal Disease and Stage 5 Chronic Kidney Disease. Completed, enrolled 8 participants across 1 site.
Detailed Summary
Chronic Kidney Disease Stage 5 (CKD5) patients receiving maintenance hemodialysis are at an increased risk for developing bloodstream infections. Vancomycin is traditionally used as first-line therapy for treating these infections, but the emergence of less-susceptible bacterial strains necessitates the consideration of alternative antibiotic therapy. Telavancin is a new antibiotic that has broad-spectrum antimicrobial activity against gram-positive bacteria, including vancomycin-intermediate staphylococcus aureus. While dosing recommendations for telavancin are available for patients with normal kidney function, there are no published recommendations for CKD5 patients receiving hemodialysis. A pharmacokinetic study is needed to characterize the pharmacokinetic parameters of telavancin in these patients to determine the extent of drug removal by hemodialysis and to establish dosing recommendations for CKD5 patients on maintenance hemodialysis.
Study Details
Timeline
Interventions
A single 5 mg/kg dose of telavancin is administered intravenously (IV).
Blood samples are collected to assess telavancin plasma concentrations.