Population Pharmacokinetics of Levofloxacin in Intensive Care Patients With Severe Community-acquired Pneumonia.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Levofloxacin dosage regimen, time of administration and time of blood sampling, levofloxacin serum concentrations.
研究概览
简要总结
The aim of this study is 1. to describe levofloxacin pharmacokinetics in ICU patients suffering from pneumonia with taking into account physio-pathological parameters. 2. to verify clinical and bacteriological efficiency and to know if the peak/Minimum Inhibitory Concentration (MIC) ratio > 5 and Area Under Curve (AUC) /Minimum Inhibitory Concentration(MIC) ratio > 125. No therapeutic drug monitoring will be performed in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe community-acquired pneumonia due to a strain sensible to levofloxacin
- •Age > 18 years
- •Informed consent
- •SAPS II (simplified acute physiological score) > 20 Awaited duration of survival higher than 7 days
排除标准
- •Historic of allergy to levofloxacin
- •Resistant strain to levofloxacin
- •Pregnancy
- •Contra-indications of levofloxacin use, renal failure
研究组 & 干预措施
Levofloxacin
Population having a community-acquired pneumonia of which the indication of the treatment is administration of Levofloxacin
干预措施: Levofloxacin (Drug)
结局指标
主要结局
Levofloxacin dosage regimen, time of administration and time of blood sampling, levofloxacin serum concentrations.
时间窗: Levofloxacin concentration assessment at 8 different time points during 12h
次要结局
- Efficiency (clinical,bacteriological, pharmacodynamic)(12 hours)