Vancomycin Dose Adjustments Comparing Trough Levels to The AUC/MIC Method Using a Bayesian Approach in a Hospitalized Adult Population

Not Applicable

Completed

• Conditions: Vancomycin; Area Under Curve; Adult

• Registration Number: NCT04756895
• Lead Sponsor: CR-CSSS Champlain-Charles-Le Moyne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-15
• Study First Posted: 2021-02-16
• Study Start: 2021-03-01
• Primary Completion: 2021-08-06
• Study Completion: 2021-08-06
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-09
• Last Update Posted: 2021-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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 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.
Proportion of acute kidney injury	During the vancomycin treatment	Percentage of acute kidney injury.
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
Operational Impact	Immediately after the intervention	Evaluation of the impact on pharmacist's time required for monitoring vancomycin
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
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.
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

Trial Locations

Locations (1)

Charles-Le Moyne Hospital; 🇨🇦 Greenfield Park, Quebec, Canada