Clinical trial NCT04756895: Vancomycin Dose Adjustments Comparing Trough Levels to The AUC/MIC Method Using a Bayesian Approach in a Hospitalized Adult Population
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vancomycin
Adult
Area Under Curve
Keywords: Bayesian approach
Dose adjustments
trough
Lead sponsor: CR-CSSS Champlain-Charles-Le Moyne
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Validation of The Research Protocol
timeFrame: Through study completion, an average of 2 weeks
measure: Evaluation of Recruitment
timeFrame: Baseline
Secondary outcomes:
measure: The proportion of patients who reach a therapeutic level in the first 48 hours
timeFrame: At 48 hours after the first dose of vancomycin
measure: Time to reach the vancomycin target
timeFrame: During the vancomycin treatment
measure: The number of adjustments required to reach the vancomycin target
timeFrame: During the vancomycin treatment
measure: The number of vancomycin dosage level monitoring to reach the vancomycin target
timeFrame: During the vancomycin treatment
measure: The proportion of vancomycin dosage level monitoring in the vancomycin target
timeFrame: During the vancomycin treatment
measure: The difference between the AUC calculated by the Bayesian method and the trapezoid method
timeFrame: During the vancomycin treatment
measure: The difference between the initial prescribed dose and the dose suggested by the Bayesian software.
timeFrame: Baseline
measure: Proportion of acute kidney injury
timeFrame: During the vancomycin treatment
measure: Average daily dose of vancomycin
timeFrame: Through study completion, an average of 2 weeks
measure: Operational Impact
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Greenfield Park
country: Canada
facility: Charles-Le Moyne Hospital
state: Quebec
Study officials:
affiliation: Charles-Le Moyne Hospital
name: Benoît Crevier, PharmD, MSc
role: PRINCIPAL_INVESTIGATOR
References: