The Pharmacodynamics of Imipenem in Critically Ill Patients With Ventilator-associated Pneumonia Following Administration by 4 h or 0.5 h Infusion
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
- 否
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
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
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
Sutep Jaruratanasirikul
Prof.Dr.Sutep Jaruratanasirikul
Prince of Songkla University
