NCT03585426Unknown4 期
Vancomycin in the Target Site Treatment of Intracranial Infection : a New Strategy for PK/PD Treatment
Xijing Hospital0 个研究点目标入组 2 人开始时间: 2016年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 2
- 主要终点
- Vancomycin concentration change in serum and cerebrospinal fluid
研究概览
简要总结
Vancomycin, a novel intravenously administered antibiotic, currently plays a key role in the management of complicated multi-organism infections. However,current LC-MS/MS methods briefly describe parameters and the only reported internal standard was sometimes difficult to obtain. In our study,an updated LC-MS/MS method for the quantitative analysis of vancomycin in human serum was developed.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In ICU; ventricle drainage was carried out; renal function is normal, namely creatinine clearance rate is >60ml/min;
排除标准
- •women in pregnancy or lactation;in patients with renal insufficiency, the creatinine clearance rate (Clcr) is less than 60ml/min.
研究组 & 干预措施
Vancomycin 1g q12h
Experimental
干预措施: Vancomycin (Drug)
Vancomycin 1g q8h
Experimental
干预措施: Vancomycin (Drug)
结局指标
主要结局
Vancomycin concentration change in serum and cerebrospinal fluid
时间窗: 0.5h, 1h, 1.5h, 3h, 5h, 7h, 9h, and 12h after treatment
Quantitative analysis of vancomycin in serum and cerebrospinal fluid after treatment by an updated LC-MS/MS method.
次要结局
未报告次要终点
研究者
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