CompletedPhase 1

Vancomycin Pharmacokinetics in Patients on Peritoneal Dialysis

United States4 participantsStarted 2018-11-15

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Maximum Total Plasma Concentration (Cmax)

Timeframe: Day: 1

Time to Maximum Plasma Concentration (Tmax)

Timeframe: Day: 1

Area Under the Concentration-time Curve (AUC0-inf)

Timeframe: Days: 1-7

Total Body Clearance (CLtotal)

Timeframe: Days: 1-7

Dialytic Clearance

Timeframe: Days: 1-7

Trial details

NCT IDNCT03685747

SponsorThomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-08-30

Results submitted2021-12-02

View on ClinicalTrials.gov More Peritoneal Dialysis-associated Peritonitis trials