Pharmacokinetics of Anidulafungin in Critically Ill Patients With Invasive Candidiasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To investigate the correlation of pharmacokinetic parameters of anidulafungin with markers for disease severity - either disease severity scores or parameters (singly, or combined) for inflammation or organ function - and plasma protein levels.
研究概览
简要总结
The objective of this study is to determine whether pharmacokinetic parameters of anidulafungin correlate with disease severity and plasma protein levels in critically ill patients.
详细描述
One of the risk factors for mortality of patients with candidemia is inadequate antifungal therapy. The first days in the intensive care unit (ICU), patients are unstable and it can be questioned whether therapeutic levels of anidulafungin are reached after a standard loading scheme. At this moment there are several clues that the PK of anidulafungin in critically ill patients is different, but an overall picture is lacking.
For the investigation of the correlation of the pharmacokinetics of anidulafungin and the disease severity a full pharmacokinetic profile will be obtained. Predictive scoring systems will be used to assess disease severity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •treatment with anidulafungin
- •at least 18 years of age
- •invasive candidiasis
- •admitted to an intensive care unit
排除标准
- •allergic to anidulafungin or its excipients
- •contra-indication stated in SPC
- •neutropenia
结局指标
主要结局
To investigate the correlation of pharmacokinetic parameters of anidulafungin with markers for disease severity - either disease severity scores or parameters (singly, or combined) for inflammation or organ function - and plasma protein levels.
时间窗: 3 days
次要结局
- Time (in days) to culture conversion(max 28 days)
- AUC/MIC ratio, time above MIC(max 28 days)
- Mortality at day 28 due to fungal infection and overall mortality at 28 days(28 days)
- Composing a pharmacokinetic model of anidulafungin in critically ill patients(max 28 days)
- Response to treatment at day 28(28 days)
研究者
JWC Alffenaar
PharmD, PhD
University Medical Center Groningen