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

NCT04756895 | Completed

• 1 other identifier: 2021-600
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

Bayesian approach; Dose adjustments; trough

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• The proportion 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

  During the vancomycin treatment

• The number of adjustments required to reach the vancomycin target

  During the vancomycin treatment

• 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

  During the vancomycin treatment

Study Arms (2)

Bayesian method

EXPERIMENTAL

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

Standard method

ACTIVE COMPARATOR

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

Other: Vancomycin dose adjustment using the trough level method

Interventions

Vancomycin dose adjustment using the Bayesian method OTHER

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

Bayesian method

Vancomycin dose adjustment using the trough level method 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.

Standard method

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age;
• Hospitalized patients
• Suspected or confirmed infection;
• Anticipated IV vancomycin treatment for 24 hours or more.

You may not qualify if:

• Patients with renal replacement therapy (peritoneal dialysis, continuous renal replacement therapy or hemodialysis);
• Treatment of vancomycin in continuous infusion;

Sponsors & Collaborators

• CR-CSSS Champlain-Charles-Le Moyne: lead

Study Sites (1)

Charles-Le Moyne Hospital

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Study Officials

• Benoît Crevier, PharmD, MSc

  Charles-Le Moyne Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 16, 2021
• Study Start: March 1, 2021
• Primary Completion: August 6, 2021
• Study Completion: August 6, 2021
• Last Updated: September 10, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)