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Completed

NCT Number: NCT04756895

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

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.

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Key information

Conditions

Vancomycin Adult Area Under Curve

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charles-Le Moyne Hospital

Greenfield Park, Quebec, J4V 2H1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Vancomycin dose adjustment using the Bayesian method

Other

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

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.

Primary outcomes

  1. Validation of The Research Protocol

    Time frame: Through study completion, an average of 2 weeks

    Evaluation of adhesion rate to the sampling protocol of 80% or more and adhesion rate to software recommendations of 90% or more

  2. Evaluation of Recruitment

    Time frame: Baseline

    Evaluation of consent rate of 30% or more and the number of patients recruited per month of 10 or more

Secondary outcomes

  1. The proportion of patients who reach a therapeutic level in the first 48 hours

    Time frame: At 48 hours after the first dose of vancomycin

    Percentage of patients who reach a therapeutic level in the first 48 hours

  2. Time to reach the vancomycin target

    Time frame: During the vancomycin treatment

    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.

  3. The number of adjustments required to reach the vancomycin target

    Time frame: During the vancomycin treatment

    Number of dose adjustments required to reach the vancomycin target

  4. The number of vancomycin dosage level monitoring to reach the vancomycin target

    Time frame: During the vancomycin treatment

    The number of vancomycin dosage level monitoring to reach the vancomycin target

  5. The proportion of vancomycin dosage level monitoring in the vancomycin target

    Time frame: During the vancomycin treatment

    Percentage of vancomycin dosage level monitoring in the vancomycin target

  6. The difference between the AUC calculated by the Bayesian method and the trapezoid method

    Time frame: During the vancomycin treatment

    Difference in percentage of the vancomycin AUC calculated by the Bayesian method and the trapezoid method

  7. The difference between the initial prescribed dose and the dose suggested by the Bayesian software.

    Time frame: Baseline

    Difference in percentage of the initial prescribed dose and the dose suggested by the Bayesian software.

  8. Proportion of acute kidney injury

    Time frame: During the vancomycin treatment

    Percentage of acute kidney injury.

  9. Average daily dose of vancomycin

    Time frame: Through study completion, an average of 2 weeks

    Average of the daily dose of vancomycin calculated in mg per kg of total body weight

  10. Operational Impact

    Time frame: Immediately after the intervention

    Evaluation of the impact on pharmacist's time required for monitoring vancomycin

Sponsors and collaborators

Lead sponsor

CR-CSSS Champlain-Charles-Le Moyne

Other

Registry information

Official study title

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

Acronym: VancoDATABayes

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 16, 2021
Registry last updated
Sep 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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