First Time Right of Vancomycin

Not Applicable

Not yet recruiting

• Conditions: Vancomycin; Pharmacokinetics
• Interventions: Drug: Vancomycin

• Registration Number: NCT05964114
• Lead Sponsor: Erasmus Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-24
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-19
• Last Update Submitted: 2023-07-19
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27
• Study Start: 2023-10
• Primary Completion: 2025-10
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• Adult patients who receive continuous vancomycin treatment at the ICU or orthopaedic department
• Patient or their legal representative is able and willing to sign the Informed Consent Form

Exclusion Criteria

• Pregnant woman
• Children
• Patients with a transplantation history
• Patients on continuous renal replacement therapy (CRRT)
• Patients receiving extracorporeal membrane oxygenation (ECMO)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Starting dose of vancomycin standard vs MIPD	Vancomycin	Comparison of vancomycin initial dosing via standard of care (flat dose adjusted for renal function) versus model informed precision dosing (starting dose adjusted using pharmacokinetic models).

Primary Outcome Measures

Name	Time	Method
Number of patients within target range of vancomycin for standard treatment versus treatment using MIPD within the first three days of treatment.	two years	The percentage of patients with a vancomycin concentration within the therapeutic range (20-25 mg/L) in the first three days after start of treatment for standard of care (flat dose adjusted for renal function) versus MIPD dosing (starting dose determined using pharmacokinetic models).