Peritoneal Dialysis-associated Peritonitis Clinical Trial
Official title:
A Prospective, Single-site, Open-label, Pharmacokinetic Study of Intermittent Intraperitoneal Vancomycin in Adult Subjects Receiving Automated Peritoneal Dialysis
Verified date | March 2022 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 4 |
Est. completion date | October 1, 2020 |
Est. primary completion date | August 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University |
United States,
Lam E, Ting Kayla Lien Y, Kraft WK, Stickle DF, Piraino B, Zhang J. Intraperitoneal pharmacokinetics of vancomycin in patients on automated peritoneal dialysis. Clin Transl Sci. 2021 Nov 9. doi: 10.1111/cts.13182. [Epub ahead of print] — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Total Plasma Concentration (Cmax) | Total systemic plasma concentration following 12-hour dwell | Day: 1 | |
Primary | Time to Maximum Plasma Concentration (Tmax) | Time (hours) to achieve the maximum plasma concentration | Day: 1 | |
Primary | Area Under the Concentration-time Curve (AUC0-inf) | AUC based on vancomycin plasma concentrations | Days: 1-7 | |
Primary | Total Body Clearance (CLtotal) | Total vancomycin plasma vancomycin clearance | Days: 1-7 | |
Primary | Dialytic Clearance | Vancomycin clearance from peritoneal dialysis | Days: 1-7 | |
Secondary | Adverse Events | Any adverse events throughout entirety of study as assessed by physician-investigator | Days: 1-7 |
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