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

Adult Clinical Trial

— VancoDATABayes  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04756895
• Other study ID #: 2021-600
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: August 6, 2021

Study information

• Verified date: September 2021
• Source: CR-CSSS Champlain-Charles-Le Moyne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 6, 2021
• Est. primary completion date: August 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Adult
• Area Under Curve
• Vancomycin

Intervention

Other:
• Vancomycin dose adjustment using the Bayesian method
This intervention is the experimental method. The AUC/MIC target is 400-600 mg*hour/L.
• 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.

Locations

Country	Name	City	State
Canada	Charles-Le Moyne Hospital	Greenfield Park	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
CR-CSSS Champlain-Charles-Le Moyne

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The proportion of patients who reach a therapeutic level in the first 48 hours	Percentage of patients who reach a therapeutic level in the first 48 hours	At 48 hours after the first dose of vancomycin
Secondary	Time to reach the vancomycin target	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.	During the vancomycin treatment
Secondary	The number of adjustments required to reach the vancomycin target	Number of dose adjustments required to reach the vancomycin target	During the vancomycin treatment
Secondary	The number of vancomycin dosage level monitoring to reach the vancomycin target	The number of vancomycin dosage level monitoring to reach the vancomycin target	During the vancomycin treatment
Secondary	The proportion of vancomycin dosage level monitoring in the vancomycin target	Percentage of vancomycin dosage level monitoring in the vancomycin target	During the vancomycin treatment
Secondary	The difference between the AUC calculated by the Bayesian method and the trapezoid method	Difference in percentage of the vancomycin AUC calculated by the Bayesian method and the trapezoid method	During the vancomycin treatment
Secondary	The difference between the initial prescribed dose and the dose suggested by the Bayesian software.	Difference in percentage of the initial prescribed dose and the dose suggested by the Bayesian software.	Baseline
Secondary	Proportion of acute kidney injury	Percentage of acute kidney injury.	During the vancomycin treatment
Secondary	Average daily dose of vancomycin	Average of the daily dose of vancomycin calculated in mg per kg of total body weight	Through study completion, an average of 2 weeks
Secondary	Operational Impact	Evaluation of the impact on pharmacist's time required for monitoring vancomycin	Immediately after the intervention