PK-PD of Caspofungin (Cancidas ®) and Drug Tolerance of Fungi to Patients With an Invasive Fungal Infection in the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
To investigate pharmacokinetics(PK) and pharmacodynamics(PD) of Caspofungin in ICU patients after received a loading dose of 70mg followed by 50mg (35mg if Child-Pugh score is 7-9), 40 patients will be recruited. Blood samplings for PK analysis will be collected on day 4 in this study. Caspofungin plasma concentrations are measured by using solid phase extraction and reverse phase high-performance liquid chromatography. Safety analyses will be taken daily during the treatment of Caspofungin. Tests for drug tolerance of fungi and efficacy assessment (clinical and mycological responses) will be taken every 3 days by clinical and mycological tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patient is admitted to ICU with APACHE-II score more than 15
- •Subject is 18 years old and older on the day of the first dosing
- •Subject with evidence of proven or probable IFI defined by modified criteria of European Organization for Research and Treatment of Cancer(EORTC)
排除标准
- •patient is known to be hypersensitive to caspofungin
- •patient's Child-Pugh score is more than 9
- •patient is prone to discontinue treatment result from lack of cost
- •patient or their guardian refuse to sign a informed consent form
- •patient concurrently receiving efavirenz, nevirapine, rifampin, systemic dexamethasone, phenytoin, carbamazepine, phenobarbital, or cyclosporine and other agents have influence on PK parameters of caspofungin
- •patient is treated with caspofungin within 24 hours
研究组 & 干预措施
Patients With IFI in ICU
40 patients receive Caspofungin for an Invasive Fungal Infection(IFI) in the Intensive Car will be recruited
干预措施: Caspofungin (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: day 4
Area under the plasma concentration versus time curve (AUC)
时间窗: day 4
次要结局
- Drug-related adverse events(End of caspofungin treatment,an expected average of 20 days)
研究者
Zhi-jie He
director,clinical research
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University