The Most Appropriate Parameter Correlates With Clinical Effectiveness of Vancomycin: Trough Drug Concentration or Area Under Curve (AUC)/Minimum Inhibitory Concentration (MIC)?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- 30-day mortality
研究概览
简要总结
The purpose of this study is to evaluate which is the most appropriate parameter correlates with clinical effectiveness of vancomycin: trough drug level or AUC/MIC.
详细描述
Several studies have shown AUC/MIC to be the better pharmacokinetic-pharmacodynamic parameter for clinical effectiveness of vancomycin. However, the 2009 consensus guideline for vancomycin therapeutic monitoring continued to recommend trough serum concentration monitoring in the clinical setting. In 2011, Patel et al showed that highly difference between AUC(72-96h) and Cmin(96h). Different dosing and creatinine clearance may reach the same trough drug level with different AUC. The investigators wonder whether trough drug level can serve as a substitute marker for AUC and as a parameter for vancomycin therapeutic monitoring.
In this study, the investigators will calculate AUC/MIC of vancomycin with published formula, analyze its correlation with patient's clinical outcome and compare that with trough drug level.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients of National Taiwan University Hospital
- •Age above or equal to 20 years old
- •Positive methicillin-resistant Staphylococcus aureus blood culture
- •Receiving vancomycin therapy for definitive use
- •Undergoing therapeutic drug monitoring (had serum vancomycin concentration level)
排除标准
- •Age below 20 years old
- •Without details of vancomycin dose and frequency
- •Vancomycin treatment shorter than 72 hours
- •Without renal function data (serum creatinine level, creatinine clearance)
- •Without infection-related clinical outcomes (lab data such as white blood cell count , seg, C reactive protein , body temperature records)
- •Receiving renal replacement therapy
- •Therapeutic drug monitoring before reaching steady state
- •With abnormal and undefined serum concentration
结局指标
主要结局
30-day mortality
时间窗: Day 30 after index date (the date of positive methicillin-resistant Staphylococcus aureus blood culture)
次要结局
- In-hospital mortality(Discharge day)
- 90-day mortality(Day 90 after index date (the date of positive methicillin-resistant Staphylococcus aureus blood culture))