NCT04756895

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: CR-CSSS Champlain-Charles-Le Moyne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Vancomycin dose adjustment using the Bayesian method	This intervention is the experimental method. The AUC/MIC target is 400-600 mg\*hour/L.
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.

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-08-06
• Completion: 2021-08-06
• First posted: 2021-02-16
• Last updated: 2021-09-10

Locations

1 site across 1 country: Canada