Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- pharmacokinetics of piperacillin continuous infusion compared to piperacillin extended infusion
研究概览
简要总结
Piperacillin-tazobactam is an acylureido-penicillin-beta-lactamase inhibitor combination and is frequently used in the empirical treatment of hospital-acquired infections because of its antipseudomonal activity. Similar to other beta-lactam antibiotics, piperacillin-tazobactam exhibits time-dependent killing and the T > MIC appears to be the best outcome predictor. Because a majority of infections are treated empirically, it is necessary to achieve a T > MIC equal to 50% of the dosing interval (50% T > MIC) against the most likely pathogens, including those with only moderate susceptibility The aim of this study is to compare the same dose of piperacillin/tazobactam administered by an extended infusion versus a continuous infusion. A pharmacokinetic study will be performed in patients treated by extended (loading dose 4 G/30 min followed by 4 X 4 G /3h) and continuous infusion (loading dose 4 G/30 min followed by 16G /24h).
A population pharmacokinetic analysis with Monte Carlo simulations will be used to determine 95% probability of target attainment (PTA95) versus MIC
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (> 18 years) admitted on the intensive care unit (surgical and medical surgery).
- •Starting a treatment with piperacillin/tazobactam
- •Signed informed consent
- •Hematocrit >= 21%
- •Available arterial line
排除标准
- •age <18 or >75 years
- •patient's weight <50 or >100 kg
- •renal insufficiency (estimated clearance < 50 ML /MIN)
- •haemodialysis
- •WBC < 1000 103 µl
- •estimated survival <5 days
- •meningitis or other proven infections of the CNS
- •IgE-mediated allergy to penicillins
- •pregnancy
- •patients having participated in another study <30 days before inclusion in the present study
- •retrospectively, marked deterioration of the renal function during the study period
- •retrospectively, treatment < 96 h
研究组 & 干预措施
extended infusion
干预措施: piperacillin extended infusion (Drug)
continuous infusion
干预措施: piperacillin continuous infusion (Drug)
结局指标
主要结局
pharmacokinetics of piperacillin continuous infusion compared to piperacillin extended infusion
时间窗: 6 hours
Determination of serum concentrations of piperacillin.
次要结局
- 95% probability of target attainment (PTA95) versus MIC of different organisms.(96 hours)