Vancomycin model-informed precision dosing
DeviceA dosing calculator is used for a posteriori calculation of vancomycin dose using a target AUC/MIC between 400-600 mg*h/L
Other names: Dosing calculator
NCT Number: NCT05535075
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
General Hospital Sint-Jan Brugge, Bruges, Belgium
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A dosing calculator is used for a posteriori calculation of vancomycin dose using a target AUC/MIC between 400-600 mg*h/L
Other names: Dosing calculator
Vancomycin treatment
Other names: Vancomycin treatment
Time frame: 48 to 72 hours after start vancomycin treatment
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
AKI categories are defined according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria from stage 1 to 3 (worst)
Time frame: 72 to 96 hours after start vancomycin treatment
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
Therapeutic AUC/MIC target range is 400-600
Time frame: From start date of vancomycin treatment until date of first vancomycin target attainment or study day 20, whichever comes first
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
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
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 stop date vancomycin treatment or study day 20, whichever comes first
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
Total exposure (AUC) during treatment
University Hospital, Ghent
Other
Impact of Model-informed Precision Dosing of Vancomycin in Adults: a Randomized, Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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