Antibiotic Pharmacokinetics in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,500
- 试验地点
- 11
- 主要终点
- Drug plasma concentration (time-dependent antibiotics)
研究概览
简要总结
The purpose of this study is to investigate the pharmacokinetic properties in critically ill patients of a few of the most used antimicrobial drugs (amikacin, linezolid, meropenem, piperacillin/tazobactam, vancomycin). The primary objective is the identification of the clinical parameters affecting the kinetics of these drugs and the study of the contribution of extracorporeal depuration techniques to the elimination of these molecules. The secondary objective is to describe and compare the therapeutic therapies adopted in the Intensive Care Units participating in the project.
For each molecule, the study will involve 300 patients admitted to Intensive Care Units. For each patient five blood samples will be collected on average, in order to measure drug plasma concentrations. Patient clinical conditions will be collected through an electronic clinical record. Finally, on the basis of those data, pharmacokinetic models will be developed to describe the evolution in time of drug plasma concentrations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •patients undergoing antibiotic therapy with amikacin, linezolid, meropenem, piperacillin/tazobactam, or vancomycin.
- •patients whose antibiotic therapy started during the stay in ICU or less than 24h before admission to ICU.
- •patients with anticipated length of stay in ICU of at least 24h.
- •patients with already-placed catheter
排除标准
- •patients undergoing antibiotic prophylaxis
- •lack of informed consent
研究组 & 干预措施
linezolid
patients treated with linezolid
干预措施: Linezolid (Drug)
meropenem
patients treated with meropenem
干预措施: Meropenem (Drug)
piperacillin/tazobactam
patients treated with piperacillin/tazobactam
干预措施: Piperacillin-tazobactam combination product (Drug)
vancomycin
patients treated with vancomycin
干预措施: Vancomycin (Drug)
结局指标
主要结局
Drug plasma concentration (time-dependent antibiotics)
时间窗: 30 min after first dose; 1 day after first dose; 2 day after first dose; 2 measures between the 3rd and the 8th day of treatment
Drug plasma concentration (concentration-dependent antibiotics)
时间窗: 30 min after first dose; immediately before second dose; peak and trough of the same dose in the 2nd day of therapy; peak and trough of the same dose between the 3rd and the 5th day of therapy
次要结局
未报告次要终点
