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| Name | Class |
|---|---|
| Belgium Health Care Knowledge Centre | OTHER_GOV |
| University Ghent | OTHER |
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The overall objective of this project is to investigate the large-scale utility of MIPD of vancomycin at point-of-care in ICU children. 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 critically ill child is challenging.
Currently, the starting dose of vancomycin is calculated on a milligram per kilogram basis, which is the same for all patients. The dose is then 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 critically ill children, 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, a reduction in patient burden, and a reduction in time to cure and duration of hospitalization.
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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, according to institutional guidelines during 30 day study period |
|
| vancomycin model-informed precision dosing | Experimental | Area Under the Concentration (AUC)-time curve/MIC-based model-informed precision dosing of vancomycin using a CE labelled dosing calculator during 30 day study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vancomycin model-informed precision dosing | Device | A CE labelled dosing calculator is used for a priori and a posteriori calculation of vancomycin dose using a target AUC between 400-600 mg*h/L |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients reaching target 24hAUC/MIC | therapeutic AUC/MIC target range is 400-600 | 24 to 48 hours after start vancomycin treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with (worsening) acute kidney injury during vancomycin treatment | AKI categories are defined according to the neonatal and pediatric RIFLE criteria | from start date of vancomycin treatment until stop date vancomycin treatment or study day 30, whichever comes first |
| Proportion of patients reaching target 24h AUC/MIC |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative number of additional blood samples during treatment in patients with clinical cure | 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 30, whichever comes first in patients with clinical cure |
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 |
|---|---|---|---|---|---|---|
| Erasme | Brussels | Brussels Capital | Belgium | |||
| AZ Sint-Jan Brugge-Oostende AV |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41974145 | Derived | De Cock PA, Colman R, Smits A, Piersigilli F, Renard M, Van Damme A, Clarysse A, Dhont E, Vanhaesebrouck S, Bordon V, Boland L, De Wilde B, Amza A, Vanlanduyt L, Nguyen TVA, Cools F, van der Werff Ten Bosch J, Vens D, Derriks F, Houtekie L, Mauel R, Van der Linden D, Schelstraete P; BENEFICIAL study group. Bedside model-informed precision dosing of vancomycin in severely ill neonates and children in Belgium (the BENEFICIAL trial): a multicentre, randomised controlled trial. Lancet Child Adolesc Health. 2026 Jun;10(6):406-417. doi: 10.1016/S2352-4642(25)00385-2. Epub 2026 Apr 10. |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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participants and parents or 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 |
|
therapeutic AUC/MIC target range is 400-600 |
| 48-72 hours after start vancomycin treatment |
| Time to clinical cure | Time to clinical cure is defined as the time interval (in days) from start to completion of the vancomycin vancomycin treatment, without recommencement of antibiotics for the same indication within 48h after stop. | 30 day study period |
| Ward unit length-of-stay | Ward unit length-of-stay is calculated from day of ward unit admission to day of ward unit discharge. | 30 day study period |
| Hospital length-of-stay | Hospital unit length-of-stay is calculated from day of hospital admission to day of hospital discharge. | 30 day study period |
| 30 day all cause mortality | 30 day all cause mortality is measured 30 days after randomisation. | 30 day study period |
| 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 30, whichever comes first |
| Proportion of patients reaching target 24h AUC/MIC | therapeutic AUC/MIC target range is 400-600 | 72-96 hours after start vancomycin treatment |
| 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 vancomycin treatment until date of first vancomycin target attainment or study day 30, whichever comes first |
| Number of trough sampling time errors | only measured for intermittent dosing regimens in the comparator arm. | from start date of vancomycin treatment until stop date vancomycin treatment or study day 30, whichever comes first |
| Cumulative vancomycin dose and AUC | Total cumulative dose and exposure (AUC) during treatment | from start date of vancomycin treatment until stop date vancomycin treatment or study day 30, whichever comes first |
| Bruges |
| Belgium |
| Cliniques universitaires de Saint Luc | Brussels | Belgium |
| Hopital universitaire de Reine Fabiola | Brussels | Belgium |
| UZ Brussel | Brussels | Belgium |
| Ghent University Hospital | Ghent | Belgium |
| UZ Leuven | Leuven | Belgium |
| D000602 |
| Amino Acids, Peptides, and Proteins |