The Pharmacodynamics of Meropenem in Patient With Ventilator-associated Pneumonia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Concentration of meropenem in plasma
研究概览
简要总结
The study was a randomized three-way crossover study. Each subject received meropenem in three regimens at room temperature consecutively: (i) bolus injection of 1 g of meropenem over 10 min every 8 h for 24 h, (ii) 3-h infusion of 1 g of meropenem via an infusion pump at a constant flow rate every 8 h for 24 h, and(iii) 3-h infusion of 2 g of meropenem via an infusion pump at a constant flow rate every 8 h for 24 h.
Clinical and laboratory data such as Age,Sex, Body weight, Electrolyte, Vital signs, APACHE II score, BUN, Cr, Blood culture will be collected.
Nine patients will be enrolled in this study. After completion of the meropenem therapy for 3 days in this study, all patients will receive other sensitive antibiotics to eradicate their bacterial infections.
Meropenem pharmacokinetic studies were carried out during administration of the third dose of each regimen (16 to 24 h after the start of each regimen). Blood samples (approximately 5 ml) were obtained by direct venipuncture at the following times: before (time zero) and 10 and 30 min and
1, 1.5, 2, 2.5, 3.5, 4, 4.5, 5, 6, and 8 h after the third dose of each regimen.
The concentrations of meropenem were determined by reverse-phase high-performance liquid chromatography.
Concentration of meropenem in plasma will be 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)
详细描述
Introduction:
Meropenem is a carbapenem antibacterial agent with a broad spectrum of activity against several pathogens. In common with other -lactams, the main pharmacokinetic/pharmacodynamic parameter that correlates with the therapeutic efficacy is the T>MIC, and administration by continuous infusion is the preferred route to maximize this parameter. However, in tropical countries the stability of meropenem is an important consideration when continuous infusion is to be used.
Objective:
The aim of this study was to demonstrate the T>MIC of meropenem when administered by a 3-h infusion compared with that when administered by bolus injection.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •The patients were eligible for the study if they met the following criteria:
- •older than 18 years
- •clinical suspicion of VAP, defined by a new and persistent infiltrate on chest radiography associated with at least one of the following-purulent tracheal secretions, temperature of 38.3 celsius or higher, or a leukocyte count higher than 10000.
排除标准
- •Patients were excluded from the study if they were pregnant or in circulatory shock (which was defined as a systolic blood pressure of 90 mmHg and poor tissue perfusion) or had documented hypersensitivity to meropenem or an estimated creatinine clearance(determined by the Cockcroft-Gault method) of 60 ml/min.
研究组 & 干预措施
1 g by bolus injection
1 g of meropenem with bolus injection every 8 h regimen
干预措施: Meropenem (Drug)
1 g by 3 h infusion
1 g of meropenem with 3 h infusion every 8 h regimen
干预措施: Meropenem (Drug)
2 g by 3 hinfusion
2 g of meropenem with 3 h infusion every 8 h regimen
干预措施: Meropenem (Drug)
结局指标
主要结局
Concentration of meropenem in plasma
时间窗: 8 hours profile after 3rd dose of meropenem
Concentration of doripenem in plasma will be 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