Pharmacokinetics/Pharmacodynamics (PK/PD) of Caspofungin in Intensive Care Unit (ICU) Patients. An Open Observational Study for Antifungal Treatment's Optimization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Alterations of Caspofungin Area Under the curve (AUC) in septic patients admitted to the Intensive Care Unit (ICU).
研究概览
简要总结
PK of Caspofungin in ICU septic patients might be changed as compared to healthy volunteers due to sepsis-related pathophysiology.
Sub-optimal plasma and tissue concentrations might be achieved in these patients when drugs are administered at the same dosage/regimen suggested for healthy volunteers.
详细描述
Open non randomized, non controlled single center study on the pharmacokinetics of caspofungin in 20 consecutive ICU patients with severe sepsis or septic shock, requiring caspofungin therapy and PK-PD evaluation for the optimization of caspofungin therapy. The aim of this study is to describe the Caspofungin PK-PD alterations in a cohort of critically ill septic patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ICU patients (>18 yrs)
- •Severe sepsis or septic shock
- •Caspofungin therapy based on clinical judgement (empiric therapy) or microbiological result (targeted therapy).
排除标准
- •Concomitant ciclosporin or rifampicin therapy.
- •Pregnancy
- •Continuous renal replacement therapy
- •Severe Liver failure (Child Pugh score > 6)
研究组 & 干预措施
Critically ill patients
20 patients consecutively admitted in the ICU with severe sepsis or septic shock requiring caspofungin therapy will be considered for this observational study.
Inclusion Criteria:
Adult ICU patients (>18 yrs) with severe sepsis or septic shock undergoing caspofungin therapy based on clinical judgement (empiric therapy) or microbiological result (targeted therapy).
Exclusion criteria:
Concomitant ciclosporin or rifampicin therapy. Pregnancy Continuous renal replacement therapy Severe Liver failure (Child Pugh score > 6)
干预措施: Caspofungin (Drug)
结局指标
主要结局
Alterations of Caspofungin Area Under the curve (AUC) in septic patients admitted to the Intensive Care Unit (ICU).
时间窗: first 24 hours after loading dose
The caspofungin AUC will be described and compared with that reported in the literature for healthy volunteers.
次要结局
- Alterations of Cmax/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin(at day 4 after loading dose)
- Alterations of AUC/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin(at day 4 after loading dose)
- Alterations of Caspofungin Area Under the curve (AUC) in septic patients admitted to the Intensive Care Unit (ICU).(at day 4 after loading dose)
- Alterations of Caspofungin maximum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).(at day 4 after loading dose)
- Alterations of Caspofungin minimum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).(at day 4 after loading dose)
- Alterations of Caspofungin volume distribution in septic patients admitted to the Intensive Care Unit (ICU).(at day 4 after loading dose)
- Alterations of Caspofungin elimination half life in septic patients admitted to the Intensive Care Unit (ICU).(at day 4 after loading dose)
研究者
Gianluca Villa
Principal investigator
Careggi Hospital