The overall objective of this project is to investigate the utility of model-informed precision dosing (MIPD) of vancomycin in non-critically ill adults. This evaluation includes a comparison with the more standard approach on clinical and patient-oriented measures.
Vancomycin is an antibiotic with a narrow therapeutic-toxic margin. This means that the minimum and maximum target blood target levels differ little from each other. Too low concentrations will reduce the effect of the antibiotic; higher concentrations may result in serious side effects, including renal toxicity. Vancomycin dosing tailored to the individual patient is challenging. Currently, the vancomycin dose is adjusted based on a measured vancomycin blood concentration (if too high or too low). Despite this measurement, quickly achieving target concentrations remains a major challenge. This multicenter, individual randomized study investigates the added value of a user-friendly computer program for calculating the vancomycin dose in non-critically ill adults, compared to the current standard-of-care. Specifically, the investigators will study whether the use of this computer program leads to a shorter time to reach target concentrations, a reduction in the number and severity of side effects on the kidney and a reduction in patient burden.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
155
A dosing calculator is used for a posteriori calculation of vancomycin dose using a target AUC/MIC between 400-600 mg\*h/L
Vancomycin treatment
General Hospital Sint-Jan Brugge
Bruges, Belgium
Ghent University Hospital
Ghent, Belgium
Proportion of patients reaching target 24h AUC/MIC
Therapeutic AUC/MIC target range is 400-600
Time frame: 48 to 72 hours after start vancomycin treatment
Proportion of patients with (worsening) acute kidney injury (AKI) during vancomycin treatment
AKI categories are defined according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria from stage 1 to 3 (worst)
Time frame: From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first
Proportion of patients reaching target 24h AUC/MIC
Therapeutic AUC/MIC target range is 400-600
Time frame: 72 to 96 hours after start vancomycin treatment
Proportion of time within therapeutic target
Therapeutic AUC/MIC target range is 400-600
Time frame: From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first
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