First Time Right of Vancomycin

Erasmus University

Status: Not yet enrolling

Conditions: Vancomycin; Pharmacokinetics

Treatments: Drug: Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT05964114

7646

Details and patient eligibility

About

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.

Enrollment: 134 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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134 participants in 1 patient group

Starting dose of vancomycin standard vs MIPD

Experimental group

Description:

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).

Treatment:

Drug: Vancomycin