Adult, Area Under Curve, Vancomycin
Conditions
Keywords
Bayesian approach, Dose adjustments, trough
Brief summary
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.
Interventions
OTHERVancomycin dose adjustment using the Bayesian method
This intervention is the experimental method. The AUC/MIC target is 400-600 mg\*hour/L.
OTHERVancomycin dose adjustment using the trough level method
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.
Sponsors
CR-CSSS Champlain-Charles-Le Moyne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age; * Hospitalized patients * Suspected or confirmed infection; * Anticipated IV vancomycin treatment for 24 hours or more.
Exclusion criteria
* Patients with renal replacement therapy (peritoneal dialysis, continuous renal replacement therapy or hemodialysis); * Treatment of vancomycin in continuous infusion;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validation of The Research Protocol | Through study completion, an average of 2 weeks | Evaluation of adhesion rate to the sampling protocol of 80% or more and adhesion rate to software recommendations of 90% or more |
| Evaluation of Recruitment | Baseline | Evaluation of consent rate of 30% or more and the number of patients recruited per month of 10 or more |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of adjustments required to reach the vancomycin target | During the vancomycin treatment | Number of dose adjustments required to reach the vancomycin target |
| The number of vancomycin dosage level monitoring to reach the vancomycin target | During the vancomycin treatment | The number of vancomycin dosage level monitoring to reach the vancomycin target |
| The proportion of vancomycin dosage level monitoring in the vancomycin target | During the vancomycin treatment | Percentage of vancomycin dosage level monitoring in the vancomycin target |
| The difference between the AUC calculated by the Bayesian method and the trapezoid method | During the vancomycin treatment | Difference in percentage of the vancomycin AUC calculated by the Bayesian method and the trapezoid method |
| The proportion of patients who reach a therapeutic level in the first 48 hours | At 48 hours after the first dose of vancomycin | Percentage of patients who reach a therapeutic level in the first 48 hours |
| Proportion of acute kidney injury | During the vancomycin treatment | Percentage of acute kidney injury. |
| Average daily dose of vancomycin | Through study completion, an average of 2 weeks | Average of the daily dose of vancomycin calculated in mg per kg of total body weight |
| Operational Impact | Immediately after the intervention | Evaluation of the impact on pharmacist's time required for monitoring vancomycin |
| The difference between the initial prescribed dose and the dose suggested by the Bayesian software. | Baseline | Difference in percentage of the initial prescribed dose and the dose suggested by the Bayesian software. |
| Time to reach the vancomycin target | During the vancomycin treatment | 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. |
Countries
Canada
Outcome results
None listed