Model-informed Precision Dosing of Vancomycin in Adults
NCT ID: NCT05535075
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
155 participants
INTERVENTIONAL
2021-11-12
2023-11-17
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Standard of Care Vancomycin treatment
Vancomycin standard-of-care dosing and therapeutic drug monitoring (TDM), according to institutional guidelines during 20 day study period
Vancomycin
Vancomycin treatment
Vancomycin model-informed precision dosing
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
Vancomycin model-informed precision dosing
A dosing calculator is used for a posteriori calculation of vancomycin dose using a target AUC/MIC between 400-600 mg\*h/L
Vancomycin
Vancomycin treatment
Interventions
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Vancomycin model-informed precision dosing
A dosing calculator is used for a posteriori calculation of vancomycin dose using a target AUC/MIC between 400-600 mg\*h/L
Vancomycin
Vancomycin treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* admitted to a participating ward unit
* a suspected or confirmed Gram positive infection
* planned to start of started on intravenous continuous infusion vancomycin treatment
* participant or legal representative signed the informed consent form
* not previously enrolled in this trial
Exclusion Criteria
* undergoing extracorporeal treatment at inclusion (e.g. extracorporeal membrane oxygenation, dialysis, body cooling)
* patient death is deemed imminent and inevitable.
18 Years
ALL
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Pieter De Cock, Prof
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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General Hospital Sint-Jan Brugge
Bruges, , Belgium
Ghent University Hospital
Ghent, , Belgium
Countries
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Other Identifiers
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2021-003670-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BC-10433
Identifier Type: -
Identifier Source: org_study_id