External Evaluation of Vancomycin Population Pharmacokinetic Models (EOPMV)

External Evaluation of Vancomycin Population Pharmacokinetic Models and Development of Continuous Infusion Dosing Recommendations

All patients treated with vancomycin hospitalized outside of ICU in Brest University Hospital from 1rst january 2019 to 1rst january 2021 will be screened for inclusion. Vancomycin dosage, age, weight and serum creatinin will be recorded.

Seven pharmacokinetic models' predictive performance will be evaluated on this database.

Using the best model, we will perform Monte-Carlo simulation to elaborate dosing nomograms and develop dosing recommandations of continuous infusion of vancomycin.

Study Overview

• Status: Completed
• Conditions: Vancomycin Dosage

Detailed Description

Monte Carlo simulations will be performed according to varying creatinin clearance values and weight, for both the loading dose and the maintenance dose.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • Brest University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adults treated with vancomycin outside of ICU

Description

Inclusion Criteria:

• All patients hospitalized in Brest University Hospital,
• treated with vancomycin and receiving pharmacological monitoring
• between 1rst January 2019 and 1rst January 2021

Exclusion Criteria:

• Missing data on vancomycin administration
• Refusal to be included in this study
• Hospitalisation in ICU

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Imprecision in Predictive performance of seven pharmacokinetic models	The model with the lesser imprecision reported on the Observed vs Predicted Concentrations Graph will be selected	September 2021
Bias in Predictive performance of seven pharmacokinetic models	The model with the lesser bias reported on the Observed vs Predicted Concentrations Graph will be selected	September 2021

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2021
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: EOPMV - 29BRC21.0126

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No