Model-informed Precision Dosing of Vancomycin in Adults
- Conditions
- Vancomycin
- Interventions
- Device: Vancomycin model-informed precision dosing
- Registration Number
- NCT05535075
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
- 18 years or older
- 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
- serum creatinine level at inclusion is above 2.5 mg/dL
- undergoing extracorporeal treatment at inclusion (e.g. extracorporeal membrane oxygenation, dialysis, body cooling)
- patient death is deemed imminent and inevitable.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care Vancomycin treatment Vancomycin Vancomycin standard-of-care dosing and therapeutic drug monitoring (TDM), according to institutional guidelines during 20 day study period Vancomycin model-informed precision dosing 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 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
- Primary Outcome Measures
Name Time Method Proportion of patients reaching target 24h AUC/MIC 48 to 72 hours after start vancomycin treatment Therapeutic AUC/MIC target range is 400-600
- Secondary Outcome Measures
Name Time Method Proportion of patients with (worsening) acute kidney injury (AKI) during vancomycin treatment 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)
Proportion of patients reaching target 24h AUC/MIC 72 to 96 hours after start vancomycin treatment Therapeutic AUC/MIC target range is 400-600
Proportion of time within therapeutic target 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
Trial Locations
- Locations (2)
Ghent University Hospital
🇧🇪Ghent, Belgium
General Hospital Sint-Jan Brugge
🇧🇪Brugge, Belgium