Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia Following Administration by 4-hour Infusion and Bolus Injection.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Concentration of imipenem in plasma
研究概览
简要总结
This is prospective and randomized study to compare the pharmacodynamics (t>MIC) of 0.5 g every 6 h of imipenem in twelve patients with febrile neutropenia following administration by a 4 h infusion or bolus injection.
Concentration of imipenem in plasma will be measured by HPLC method and simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T>MIC) and reported to %PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response.
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 febrile neutropenia with Gram negative bacilli infections which are sensitive to imipenem by the disk diffusion
- •Patients who are likely to survive 3 days
排除标准
- •Patients who have documented hypersensitivity to imipenem or other carbapenems
- •Patients who have an estimated creatinine clearance of < 50 ml/min
- •Patients who are in circulatory shock or hypotension (systolic < 90 mmHg)
- •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 2-5 days
干预措施: Imipenem (Drug)
Extended infusion arm
Infusion of 0.5 g of imipenem for 4 hr every 6 hr for 2-5 days
干预措施: Imipenem (Drug)
结局指标
主要结局
Concentration of imipenem in plasma
时间窗: 6 hours profile after 8th dose of imipenem
Concentration of imipenem in plasma will be determined by HPLC method and simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T\>MIC) and reported to % PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response).
次要结局
未报告次要终点
研究者
Sutep Jaruratanasirikul
Principal Investigator
Prince of Songkla University