Prospective Trial to Evaluate Pharmacokinetic, Safety and Efficacy of Intermittent Application of Increased Doses of Caspofungin for Antifungal Prophylaxis in High Risk Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- caspofungin pharmacokinetic
研究概览
简要总结
The study is a pilot phase II, prospective, non-comparative, single center trial aimed to evaluate pharmacokinetic and safety of an intermittent dosing schedule for antifungal prophylaxis in high risk patients.
详细描述
Pharmacokinetic and safety of caspofungin, in an intermittent dosing schedule, for prophylaxis of invasive fungal (IFI) infections will be evaluated in patients receiving induction chemotherapy for treatment of acute myeloid leukemia, myelodysplastic syndrome with blast crisis or acute lymphatic leukemia.
For prophylaxis caspofungin once daily will be given three times a week after a loading phase of three days. For drug monitoring serum samples will be collected from the first day of trial medication till one day after end of therapy (EOT). Invasive fungal infections will be diagnosed analog the criteria defined by the European organization for Research and Treatment of Cancer and the Mycosis Study Group (EORTC/MSG), revised in 2008.
Caspofungin prophylaxis will be stopped after the end of neutropenia, in case of documented proven or probable invasive fungal disease and in case of a serious adverse event attributable to the study drug, for which in view of the investigator further usage of the study drug should be avoided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •acute myeloid leukemia or myelodysplastic syndrome and blast crisis or acute lymphatic leukemia
- •receiving induction chemotherapy
排除标准
- •current or need of systemic antifungal therapy
- •history of proven or probable invasive aspergillus infection
- •pregnant or breastfeeding women
- •weight more than 100 kg
- •history of allergy, hypersensitivity or any serious reaction to caspofungin
研究组 & 干预措施
Caspofungin
干预措施: caspofungin (Drug)
结局指标
主要结局
caspofungin pharmacokinetic
时间窗: day 20 (average), till end of enutropenia
To characterize the pharmacokinetic of caspofungin IV solution in an intermittent dosing schedule of 3 times a week after a 3 days loading in a representative subject population.
次要结局
- Safety of intermittent caspofungin(day 34 (average), 2 weeks after end of neutropenia)
- Caspofungin pharmacokinetic(day 20 (average), at end of neutropenia)
- Incidence of invasive fungal disease and outcome(day 100 after start of chemotherapy)
研究者
Werner J. Heinz
Consultant Infectious Diseases
Wuerzburg University Hospital