跳至主要内容
临床试验/NCT03858387
NCT03858387Unknown不适用

Pharmacokinetics/Pharmacodynamics and Clinical Outcomes of β-lactams in Critically Ill Patients

Prince of Songkla University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2018年9月1日最近更新:
适应症
干预措施
相关药物

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sutep Jaruratanasirikul

Department of Medicine, Faculty of Medicine, Prince of Songkla University

Prince of Songkla University

研究点 (1)

Loading locations...

相似试验