Pharmacokinetics/Pharmacodynamics and Clinical Outcomes of β-lactams in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Population pharmacokinetic parameters of meropenem and imipenem
研究概览
简要总结
Meropenem and imipenem are broad-spectrum carbapenem antibiotic and are frequently prescribed in critically ill patients with severe infections. These patients show several pathophysiological changes that may alter the carbapenem pharmacokinetic (PK) normally found in other populations. Although the PK of carbapenems has been widely studied, most studies have been conducted on small populations, and clinical outcome data are sparse. Therefore, the aims of this study are (i) describe the population pharmacokinetic parameters of meropenem and imipenem in critically ill subject (ii) evaluate the pharmacodynamic of meropenem and imipenem as a predictor of clinical treatment outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •age >18 years
- •severely ill patient who admitted to medical or surgical intensive care unit who require a treatment with meropenem or imipenem antibiotic
排除标准
- •severe renal impairment and require renal replacement therapy
- •APACHE II score >30
- •History of hypersensitivity to carbapenems
- •Pregnancy or breast-feeding female
研究组 & 干预措施
Meropenem
Critically ill patients who require meropenem therapy
干预措施: Meropenem (Drug)
Imipenem
Critically ill patients who require imipenem therapy
干预措施: Imipenem (Drug)
结局指标
主要结局
Population pharmacokinetic parameters of meropenem and imipenem
时间窗: 24-48 hours after treatment
%fT>MIC of meropenem and imipenem
时间窗: 24-48 hours after treatment
the percentage of time which the free drug concentration remains above the minimum inbibitory concentration (%fT\>MIC)
次要结局
- The relationship between %fT>MIC and mortality(during hospital stay and at day 28)
- The relationship between %fT>MIC and clinical cure(Day 3-7 after treatment and end of therapy (7-14))
- The relationship between %fT>MIC and microbiological cure(Day 3-7 after treatment and end of therapy (7-14))
研究者
Sutep Jaruratanasirikul
Department of Medicine, Faculty of Medicine, Prince of Songkla University
Prince of Songkla University
