Anidulafungin Population Kinetics in the Intensive Care Population
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Pharmacokinetic population model for anidulafungin for the ICU population
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetics of anidulafungin in intensive care patients.
详细描述
Not a lot is known about the pharmacokinetic profile of anidulafungin in IC-patients. IC-patients are at high(er) risk for getting a systemic mould/yeast infection. Anidulafungin is a safe echinocandin with, so far, no reported interactions and few adverse effects. Due to this, anidulafungin is used more often on IC-wards. It is part of the national (Netherlands) IC sepsis protocol. The factors that influence the pharmacokinetics of anidulafungin in IC-patients has not been studied yet. Because these factors are unknown for this population, it is necessary for this research to be done.
Any patient with an (suspected) invasive candidiasis whom is treated with anidulafunging can be includen.
20 patients will be included from 2 different university hospital (10 each). Samples will be taken on different days and timepoints, troughlevels on all treatment days and on treatment day 3 and 7 more samples will be taken voor AUC calculations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patient is admitted to the intensive care unit
- •Patient has a central (venous) infusion line
- •Patient is at least 18 years old
- •Patient receives treatment with anidulafungin
- •that is initiated on the ICU or
- •that is continued on the ICU and the patient has had no more than 2 days of treatment with anidulafungin
排除标准
- •Documented history of sensitivity to medicinal products or excipients similar to those found in the anidulafungin preparation
- •Patient receives treatment with anidulafungin that is continued on the ICU and the patient has had 3 or more days of treatment with anidulafungin
- •A woman that is pregnant, wanting to become pregnant or nursing an infant
- •< 48 hours (expected) treatment with anidulafungin on the ICU ward
- •Has previously participated in this trial.
结局指标
主要结局
Pharmacokinetic population model for anidulafungin for the ICU population
时间窗: 1 year, after inclusion of 20 patients
The populationmodel will be created with NONMEM. The concentrations in the bloodsamples will be the input source for this model.
次要结局
- Time until clinical and microbiological response is reached(1 year, after inclusion of 20 patients)
- To determine the covariates that influence the kinetics of anidulafungin.(1 year, after inclusion of 20 patients)
- To determine the optimal dosage(scheme) for intensive care patients.(1 year, after inclusion of 20 patients)
- Registration of side effects and adverse events(1 year, after inclusion of 20 patients)
- To determine which of the two ratios is the most predictive voor clinical outcome: AUC/MIC or Cmax/MIC.(1 year, after inclusion of 20 patients)
研究者
V.M. Middel-Baars
PharmD, hospital pharmacist trainee
Amsterdam UMC, location VUmc