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

Vancomycin Dose Adjustments Comparing Trough Levels to The AUC0-24h/MIC Method Using a Bayesian Approach in a Hospitalized Adult Population: A Pilot Study

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 Overview

• Status: Completed
• Conditions: Adult; Vancomycin; Area Under Curve
• Intervention / Treatment: Other: Vancomycin dose adjustment using the Bayesian method; Other: Vancomycin dose adjustment using the trough level method

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Charles-Le Moyne Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bayesian method; Pharmacists will perform vancomycin dose adjustments according to AUC0-24h/MIC using the Bayesian method with a web application	Other: Vancomycin dose adjustment using the Bayesian method; This intervention is the experimental method. The AUC/MIC target is 400-600 mg*hour/L.
Active Comparator: Standard method; Pharmacists will perform vancomycin dose adjustments according to trough levels of vancomycin.	Other: Vancomycin 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	During the vancomycin treatment
The number of adjustments required to reach the vancomycin target	Number of dose adjustments required to reach the vancomycin target	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	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	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	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.	Baseline
Proportion of acute kidney injury	Percentage of acute kidney injury.	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	Through study completion, an average of 2 weeks
Operational Impact	Evaluation of the impact on pharmacist's time required for monitoring vancomycin	Immediately after the intervention

Collaborators and Investigators

• Sponsor: CR-CSSS Champlain-Charles-Le Moyne
• Investigators: Principal Investigator: Benoît Crevier, PharmD, MSc, Charles-Le Moyne Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): August 6, 2021
• Study Completion (Actual): August 6, 2021

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 9, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: trough; Bayesian approach; Dose adjustments
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: 2021-600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No