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External Evaluation of Vancomycin Population Pharmacokinetic Models

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05481788
Acronym
EOPMV
Enrollment
300
Registered
2022-08-01
Start date
2021-04-16
Completion date
2021-11-01
Last updated
2022-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vancomycin Dosage

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.

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.

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Imprecision in Predictive performance of seven pharmacokinetic modelsSeptember 2021The model with the lesser imprecision reported on the Observed vs Predicted Concentrations Graph will be selected
Bias in Predictive performance of seven pharmacokinetic modelsSeptember 2021The model with the lesser bias reported on the Observed vs Predicted Concentrations Graph will be selected

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026