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临床试验/NCT01379157
NCT01379157已完成4 期

The Pharmacodynamics of Imipenem in Critically Ill Patients With Ventilator-associated Pneumonia Following Administration by 4 h or 0.5 h Infusion

Prince of Songkla University1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
8
试验地点
1
主要终点
Accessed PK/PD parameters

研究概览

简要总结

Imipenem is a carbapenem antibacterial agent with a broad spectrum of activity against Gram-negative and Gram-positive bacteria. This agent is often used as the last line of therapy for highly resistant Gram negative bacilli nosocomial infections. In common with other beta-lactamase inhibitor, the main pharmacokinetic/pharmacodynamic (PK/PD) index that correlates with the therapeutic efficacy is the time that concentrations in the tissue and serum are above the MIC and administration by continuous infusion is the preferred mode of administration to maximize this parameter.

However, in tropical countries, the stability of carbapenem antibiotics is an important consideration when considering continuous infusion. Therefore, prolonged infusion may be a useful mode of administration to maximize bactericidal activity. This study will demonstrate the stability of imipenem in clinical use at room temperature in tropical countries.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged > or = 20 years
  • Patients who have VAP with Gram negative bacilli infections which are sensitive to imipenem by the disk diffusion

排除标准

  • Patients who have documented hypersensitivity to imipenem or other carbapenems
  • Patients who have an estimated creatinine clearance of < or = 60 ml/min
  • Patients who are in circulatory shock
  • Patients who are pregnant

研究组 & 干预措施

Conventional arm

Active Comparator

Infusion of 0.5 g of imipenem for 0.5 hr every 6 hr for 3-5 days

干预措施: Imipenem (Drug)

Extended infusion arm

Experimental

Infusion of 1 g of imipenem for 4 hr every 8 hr for 3-5 days

干预措施: Imipenem (Drug)

结局指标

主要结局

Accessed PK/PD parameters

时间窗: 24 hours profile after first dose of trail drug.

- To determine plasma Imipenem PK/PD parameters (the PK/PD index (T\>MIC), the probability of target attainment (PTA) at 40% (T\>MIC), the cumulative fraction of response (CFR))after 4 hr infusion of 1 gm every 8 hr compared to 0.5 hr infusion of 0.5 gm every 6 hr. Conventional arm: after first dose, blood samples will be obtained by direct venepuncture at: time 0, 0.5, 6, 6.5, 12, 12.5, 18, 18.25, 18.5, 18.75, 20, 21, 22 and 24 hr Extended infusion arm: after first dose, blood samples will be obtained by direct venepuncture at: time 0, 4, 8, 12, 16, 16.5, 17, 18, 20, 20.5, 21, 22, and 24 hr

次要结局

未报告次要终点

研究者

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

Sutep Jaruratanasirikul

Prof.Dr.Sutep Jaruratanasirikul

Prince of Songkla University

研究点 (1)

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