Population Pharmacokinetics of Linezolid in Intensive Care Units Patients Treated for Methicillin-Resistant Staphylococcus Aureus (MRSA) Infections
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- The first objective of this study is to research the influence of patients' characteristic on the pharmacokinetics of Linezolid.
研究概览
简要总结
Linezolid is the first of a new class of antibacterial drugs, the oxazolidinones. It has a specific inhibitory activity against Gram positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
Dosage of 600 mg discontinuous administration twice a day was about studies in safety volunteers. The intensive care units patients, with mechanical ventilation, and with severe sepsis, represent highly heterogeneous population responsible of hight variability in pharmacokinetics parameters (augmentation in total volume of distribution, modification in glomerular filtration) wich can lead to antibiotic inefficacy.
In a first time, this study describe the pharmacokinetics of Linezolid in intensive care units patients with severe MRSA infection. The aim of this study is to define and validate a population pharmacokinetic model including the influence of patients' characteristic on the pharmacokinetics of Linezolid.
详细描述
The demographic, clinical and biological parameters are collected. Patients receive Linezolid as 600 mg twice a day during an administration of 60 minutes.
Blood sampling are collected on the second day after beginning of treatment at the following time : H1, H2, H3, H6 and H12.
The population pharmacokinétics analysis will be carried out using Monolix, a software for the analysis of nonlinear mixed effects models.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •In-patient stay in intensive care
- •Over 18 years old
- •Presenting with MRSA nosocomial pneumonia or bacteraemia with a strain thought to be sensitive to Linezolid
- •Simplified Acute Physiological Score (SAPS) II > 20
- •Expected duration of life > 7 days.
排除标准
- •History of allergy to linezolid or any of the antibiotics used
- •Isolation of MRSA resistant to linezolid
- •Lack of seeds
- •Pregnancy and lactation
研究组 & 干预措施
MRSA Infections
Methicillin-Resistant Staphylococcus aureus Infections
干预措施: Linezolid (Drug)
结局指标
主要结局
The first objective of this study is to research the influence of patients' characteristic on the pharmacokinetics of Linezolid.
时间窗: Blood sampling are collected on the second day after begining of treatment at the following time : H1, H2, H3, H6 and H12.
The following demographic, clinical and biological parameters were collected as possible covariates: age, gender, bodyweight, height, etiology of incoming, mechanical ventilation, serum creatinine, proteins, Blood Urea Nitrogen (BUN), leukocyte counts, haemoglobin, C-reactive protein (CRP), and simplified acute physiology scores (SAPS I and II).
次要结局
- The secondary outcome measure are the verification of the clinical and bactériological efficacies, and to look after the residual concentration(At the 48th hours of treatment)