NCT05964114

First Time Right of Vancomycin

Prospective Individualization of the First Vancomycin Dose Using Population Pharmacokinetic Models.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In 2020, only 16% of the Intensive Care Unit (ICU) patients achieved therapeutic drug concentrations after continuous administration of the first vancomycin dose. Many beneficial population pharmacokinetic (PPK) models are available however these are prevented from being widely implemented in daily practice due to the complexity. The aim of this study is to evaluate the effectiveness of individualized dosing with PPK models using a newly developed user-friendly pharmacokinetic (PK) tool. In a preceding retrospective study, the percentage of patients within the target range after initiation of continuous vancomycin increased from 28% to 39% (excluding CRRT and ECMO patients) with calculated concentrations based on theoretical dose adjustments. In this study we want to prospectively evaluate the concentration of vancomycin at 24, 28 and 72 hours after the start of treatment with individualized dosages based on (a combination) of available PPK models in 134 adult ICU and orthopedic patients.

Conditions

• Vancomycin
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Vancomycin	Initial dosing based on (a combinations of) pharmacokinetic models tailored to the individual patient. Dose adjustment starting dose (within registered dosing range).

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-10-01
• Completion: 2026-06-01
• First posted: 2023-07-27
• Last updated: 2023-07-27