A Phase 4 interventional study of Vancomycin model-informed precision dosing and Vancomycin in Vancomycin, sponsored by University Hospital, Ghent. Completed at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-01.
Sponsored by University Hospital, Ghent · Phase 4, Interventional, and Treatment
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.
University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vancomycin standard-of-care dosing and therapeutic drug monitoring (TDM), according to institutional guidelines during 20 day study period
Drug: Vancomycin
Area Under the Concentration-time curve ((AUC)/Minimal Inhibitory Concentration (MIC)-based model-informed precision dosing of vancomycin using a dosing calculator during 20 day study period
Device: Vancomycin model-informed precision dosing · Drug: Vancomycin
A dosing calculator is used for a posteriori calculation of vancomycin dose using a target AUC/MIC between 400-600 mg\*h/L
Also known as: Dosing calculator
Vancomycin treatment
Also known as: Vancomycin treatment
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
Number of (additional) blood samples to first target attainment during vancomycin treatment
An additional blood sample is defined as a sample for vancomycin TDM taken at another timepoint of routine biochemical monitoring samples.
Time frame: From start date of vancomycin treatment until date of first vancomycin target attainment or study day 20, whichever comes first
Cumulative number of (additional) blood samples
An additional blood sample is defined as a sample for vancomycin TDM taken at another timepoint of routine biochemical monitoring samples.
Time frame: From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first
Number of dose adjustments to first target attainment
Target in Model-Informed Precision Dosing arm: 24h AUC/MIC : 400-600; in comparator arm: target concentration range according to institutional guidelines
Time frame: From start date of vancomycin treatment until date of first vancomycin target attainment or study day 20, whichever comes first
Cumulative vancomycin dose
Total cumulative exposure (AUC) during treatment
Time frame: From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first
Cumulative vancomycin AUC
Total exposure (AUC) during treatment
Time frame: From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Ghent