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EOPMV: External Evaluation of Vancomycin Population Pharmacokinetic Models

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT05481788
Collaborator
(none)
300
Enrollment
1
Location
6.5
Actual Duration (Months)
45.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    External Evaluation of Vancomycin Population Pharmacokinetic Models and Development of Continuous Infusion Dosing Recommendations
    Actual Study Start Date :
    Apr 16, 2021
    Actual Primary Completion Date :
    Oct 1, 2021
    Actual Study Completion Date :
    Nov 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Imprecision in Predictive performance of seven pharmacokinetic models [September 2021]

      The model with the lesser imprecision reported on the Observed vs Predicted Concentrations Graph will be selected

    2. Bias in Predictive performance of seven pharmacokinetic models [September 2021]

      The model with the lesser bias reported on the Observed vs Predicted Concentrations Graph will be selected

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brest University Hospital Brest France 29200

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT05481788
    Other Study ID Numbers:
    • EOPMV - 29BRC21.0126
    First Posted:
    Aug 1, 2022
    Last Update Posted:
    Aug 1, 2022
    Last Verified:
    Jul 1, 2022
    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

    Study Results

    No Results Posted as of Aug 1, 2022