Brest University Hospital
Brest, 29200, France
Completed
NCT Number: NCT05481788
External Evaluation of Vancomycin Population Pharmacokinetic Models
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
Monte Carlo simulations will be performed according to varying creatinin clearance values and weight, for both the loading dose and the maintenance dose.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Imprecision in Predictive performance of seven pharmacokinetic models
Time frame: September 2021
The model with the lesser imprecision reported on the Observed vs Predicted Concentrations Graph will be selected
-
Bias in Predictive performance of seven pharmacokinetic models
Time frame: September 2021
The model with the lesser bias reported on the Observed vs Predicted Concentrations Graph will be selected
Sponsors and collaborators
Lead sponsor
University Hospital, Brest
Other
Registry information
Official study title
External Evaluation of Vancomycin Population Pharmacokinetic Models and Development of Continuous Infusion Dosing Recommendations
Acronym: EOPMV
Important dates
- Study start
- 2021
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- Aug 1, 2022
- Registry last updated
- Aug 1, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.