Conditions: End-Stage Renal Disease Stage 5 Chronic Kidney Disease
Keywords: telavancin end-stage renal disease ESRD pharmacokinetics hemodialysis chronic kidney disease CKD dialysis Vibativ
Allocation: NON_RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 8
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin before their normally scheduled hemodialysis session. arm 2: Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin immediately after their normally scheduled hemodialysis session.

Interventions: intervention 1: Telavancin intervention 2: Pharmacokinetic Blood Sampling
Intervention descriptions: intervention 1: A single 5 mg/kg dose of telavancin is administered intravenously (IV). intervention 2: Blood samples are collected to assess telavancin plasma concentrations.

Protocol document: