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

C

CR-CSSS Champlain-Charles-Le Moyne

Status

Completed

Conditions

Area Under Curve
Vancomycin
Adult

Treatments

Other: Vancomycin dose adjustment using the Bayesian method
Other: Vancomycin dose adjustment using the trough level method

Study type

Interventional

Funder types

Other

Identifiers

NCT04756895
2021-600

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 2 patient groups

Bayesian method
Experimental group
Description:
Pharmacists will perform vancomycin dose adjustments according to AUC0-24h/MIC using the Bayesian method with a web application
Treatment:
Other: Vancomycin dose adjustment using the Bayesian method
Standard method
Active Comparator group
Description:
Pharmacists will perform vancomycin dose adjustments according to trough levels of vancomycin.
Treatment:
Other: Vancomycin dose adjustment using the trough level method

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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