This pilot study is a prospective, randomized, controlled, open-label trial to assess the feasibility of a randomized controlled trial of sufficient quality that would assess the efficacy and safety of vancomycin adjustments according to Area under the curve/Minimal inhibitory concentration (AUC0-24h/MIC) calculated by the Bayesian approach rather than by a trough dosage. Randomization will be stratified according to infection severity. Approximately 60 subjects meeting all inclusion and no exclusion criteria will be randomized to have pharmacists perform vancomycin dose adjustments with AUC0-24h / MIC calculated by the Bayesian approach versus the trough dosage approach.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
This intervention is the experimental method. The AUC/MIC target is 400-600 mg\*hour/L.
This intervention is the standard method. Previous clinical guidelines recommended this method. The trough target is 10-15 mg/L for non-severe infections and 15-20 mg/L for severe infections.
Charles-Le Moyne Hospital
Greenfield Park, Quebec, Canada
Validation of The Research Protocol
Evaluation of adhesion rate to the sampling protocol of 80% or more and adhesion rate to software recommendations of 90% or more
Time frame: Through study completion, an average of 2 weeks
Evaluation of Recruitment
Evaluation of consent rate of 30% or more and the number of patients recruited per month of 10 or more
Time frame: Baseline
The proportion of patients who reach a therapeutic level in the first 48 hours
Percentage of patients who reach a therapeutic level in the first 48 hours
Time frame: At 48 hours after the first dose of vancomycin
Time to reach the vancomycin target
Number of hours necessary to reach the vancomycin target. Number of hours will be classified in the following categories: 24-48 hours, 49-96 hours, 97 hours and above.
Time frame: During the vancomycin treatment
The number of adjustments required to reach the vancomycin target
Number of dose adjustments required to reach the vancomycin target
Time frame: During the vancomycin treatment
The number of vancomycin dosage level monitoring to reach the vancomycin target
The number of vancomycin dosage level monitoring to reach the vancomycin target
Time frame: During the vancomycin treatment
The proportion of vancomycin dosage level monitoring in the vancomycin target
Percentage of vancomycin dosage level monitoring in the vancomycin target
Time frame: During the vancomycin treatment
The difference between the AUC calculated by the Bayesian method and the trapezoid method
Difference in percentage of the vancomycin AUC calculated by the Bayesian method and the trapezoid method
Time frame: During the vancomycin treatment
The difference between the initial prescribed dose and the dose suggested by the Bayesian software.
Difference in percentage of the initial prescribed dose and the dose suggested by the Bayesian software.
Time frame: Baseline
Proportion of acute kidney injury
Percentage of acute kidney injury.
Time frame: During the vancomycin treatment
Average daily dose of vancomycin
Average of the daily dose of vancomycin calculated in mg per kg of total body weight
Time frame: Through study completion, an average of 2 weeks
Operational Impact
Evaluation of the impact on pharmacist's time required for monitoring vancomycin
Time frame: Immediately after the intervention
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