Vancomycin
Conditions
Keywords
vancomycin, model-informed precision dosing, dose calculator, non-critically ill adults
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.
Interventions
A dosing calculator is used for a posteriori calculation of vancomycin dose using a target AUC/MIC between 400-600 mg\*h/L
DRUGVancomycin
Vancomycin treatment
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of (additional) blood samples to first target attainment during vancomycin treatment | 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. |
| Cumulative vancomycin AUC | From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first | Total exposure (AUC) during treatment |
| Cumulative number of (additional) blood samples | 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. |
| Number of dose adjustments to first target attainment | 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 |
| Cumulative vancomycin dose | From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first | Total cumulative exposure (AUC) during treatment |
Countries
Belgium
Outcome results
None listed