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临床试验/NCT05481788
NCT05481788已完成不适用

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

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年4月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Imprecision in Predictive performance of seven pharmacokinetic models

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Imprecision in Predictive performance of seven pharmacokinetic models

时间窗: 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

时间窗: September 2021

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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