Phase 1
N=4
Vancomycin Pharmacokinetics in Patients on Peritoneal Dialysis
Peritoneal Dialysis-associated Peritonitis
Bottom Line
View on ClinicalTrials.gov: NCT03685747 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Maximum Total Plasma Concentration (Cmax) — 28.7 mg/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Vancomycin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thomas Jefferson University
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Total Plasma Concentration (Cmax) |
28.7 | — |
| PRIMARY Time to Maximum Plasma Concentration (Tmax) |
14.4 | — |
| PRIMARY Area Under the Concentration-time Curve (AUC0-inf) |
2589.9 | — |
| PRIMARY Total Body Clearance (CLtotal) |
7.2 | — |
| PRIMARY Dialytic Clearance |
11.1 | — |
| SECONDARY Adverse Events |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03685747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.