Vancomycin Pharmacokinetics in Patients on Peritoneal Dialysis

• Status: Completed
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Vancomycin is the most commonly used empiric treatment for infectious peritonitis in patients on peritoneal dialysis. Current dosing and monitoring for safety and efficacy is empiric, especially for those on rapid-cycling modalities. The goal of this study is to understand the pharmacokinetics of vancomycin in patients on rapid-cycling peritoneal dialysis modalities in order to derive an optimal dosing regimen.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Treatments: Vancomycin

Criteria

Inclusion Criteria:

• Adult male or females between 18 - 85 years old

• Stabilized on a PD regimen for > 3 months prior to study initiation

Exclusion Criteria:

• Clinically significant disease unrelated to renal impairment or deemed unfit by the investigator

• Allergy or hypersensitivity to vancomycin or icodextrin-containing dialysis solution

• Active peritonitis infection

• Previous intraperitoneal antibiotic treatment within 2 months

• Previous intravenous vancomycin treatment within 2 months

• Hemoglobin < 9 g/dL

• Pregnant or breast-feeding women