Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5
Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
University of Michigan
Collaborators:
Theravance Biopharma Theravance Biopharma Antibiotics, Inc.