Pharmacokinetics and Pharmacodynamics of Colistin in Critically Ill Patients With Severe Infections for Dose Optimization Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pharmacokinetic profile; Cmax (maximum reach concentration)/ MIC( Minimum inhibitory concentration) >10
研究概览
简要总结
Phase II clinical trial, open-labelled, prospective and single-center study directed to obtain blood samples in experimental detailed conditions in order to compare and optimize the dose of colistin in critically ill patients suffering from infections on which the indication of colistin would be accepted according to normal local protocols for severe infections treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •More than 60 Kg of weigh
- •Patients with directed treatment with colistin as the recommended antimicrobial treatment protocols in the hospital to treat some of the following serious infections caused by carbapenems resistant A. baumannii: (i) bacteremia; (ii) nosocomial pneumonia or (iii) infection of skin and soft tissue (cellulitis, abscesses or infected ulcers).
- •Written informed consent form.
排除标准
- •Refractory shock or other illness with an expectative of life ˂ 48 hours after the recruitment;
- •Patient declared not to resuscitation maneuvers;
- •Suspicion or demonstration of endocarditis, osteomyelitis, or meningitis;
- •Known hypersensitivity to polymyxins;
- •Pregnancy.
研究组 & 干预措施
Colistin 6 million units + 240mg/8h
Loading dose of 6 million units of colistin+ 240mg/8h maintenance
干预措施: Colistin 6 million units + 240mg/8h (Drug)
Colistin 6 million units + 360mg/12h
Loading dose of 6 million units of colistin+ 360mg/12h maintenance
干预措施: Colistin 6 million units + 360mg/12h (Drug)
结局指标
主要结局
Pharmacokinetic profile; Cmax (maximum reach concentration)/ MIC( Minimum inhibitory concentration) >10
时间窗: Day 1 and day 3 after treatment
Plasma concentration will be measured for pharmacokinetic and pharmacodynamic profile the samples were drawn at 60, 120, 180, 240, 360, and 480 min after the end of the loading dose infusion and in patients of the group B, two more samples are taken at 600 and 720 min after the loading dose. Main pharmacokinetic parameters will be Cmax (maximum reach concentration)/ MIC(Minimum inhibitory concentration)\>10
次要结局
- Number of drug adverse reactions(21 days of follow-up)
- Pharmacodynamic profile ("Monte-Carlo simulation" (statistical methodology) with MIC (Minimum inhibitory concentration) 50 y MIC (Minimum inhibitory concentration) 90 from samples isolation)(Day 1 and day 3 after treatment)