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

NCT ID: NCT04756895

Last Updated: 2021-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-08-06

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.

Conditions

Vancomycin; Adult; Area Under Curve

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bayesian method

Pharmacists will perform vancomycin dose adjustments according to AUC0-24h/MIC using the Bayesian method with a web application

Group Type: EXPERIMENTAL

Vancomycin dose adjustment using the Bayesian method

Intervention Type: OTHER

This intervention is the experimental method. The AUC/MIC target is 400-600 mg\*hour/L.

Standard method

Pharmacists will perform vancomycin dose adjustments according to trough levels of vancomycin.

Group Type: ACTIVE_COMPARATOR

Vancomycin dose adjustment using the trough level method

Intervention Type: OTHER

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.

Interventions

Vancomycin dose adjustment using the Bayesian method

This intervention is the experimental method. The AUC/MIC target is 400-600 mg\*hour/L.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CR-CSSS Champlain-Charles-Le Moyne

OTHER

Sponsor Role: lead

Responsible Party

Benoit Crevier

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benoît Crevier, PharmD, MSc

Role: PRINCIPAL_INVESTIGATOR

Charles-Le Moyne Hospital

Locations

Charles-Le Moyne Hospital

Greenfield Park, Quebec, Canada

Countries

Canada

Other Identifiers

2021-600

Identifier Type: -

Identifier Source: org_study_id