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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003670-31 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Vancomycin treatment | Active Comparator | Vancomycin standard-of-care dosing and therapeutic drug monitoring (TDM), according to institutional guidelines during 20 day study period |
|
| Vancomycin model-informed precision dosing | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin model-informed precision dosing | Device | A dosing calculator is used for a posteriori calculation of vancomycin dose using a target AUC/MIC between 400-600 mg*h/L |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients reaching target 24h AUC/MIC | Therapeutic AUC/MIC target range is 400-600 | 48 to 72 hours after start vancomycin treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From start date of vancomycin treatment until date of first vancomycin target attainment or study day 20, whichever comes first |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pieter De Cock, Prof | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital Sint-Jan Brugge | Bruges | Belgium | ||||
| Ghent University Hospital |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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Participants and legal representatives are blinded for the allocation to the intervention or standard-of-care arm until the end of study. The statistician is kept blinded until after data analysis.
|
| Vancomycin | Drug | Vancomycin treatment |
|
|
| Proportion of patients reaching target 24h AUC/MIC |
Therapeutic AUC/MIC target range is 400-600 |
| 72 to 96 hours after start vancomycin treatment |
| Proportion of time within therapeutic target | Therapeutic AUC/MIC target range is 400-600 | From start date of vancomycin treatment until stop date vancomycin treatment 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. | 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 | 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 | 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 | From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first |
| Ghent |
| Belgium |
| D000602 |
| Amino Acids, Peptides, and Proteins |