EUCTR2009-014527-23-AT进行中（未招募）不适用
Anidulafungin in patients with hematologic malignancies - An open-label, prospective study to evaluate the safety profile at prophylactic and therapeutic dosages - ECALTA
KH der Elisabethinen Linz GmbH, I. Interne Abteilung0 个研究点开始时间: 2009年9月15日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Adult patients (>17 years) with a hematologic disorder AND an indication for IFI prophylaxis or therapy, but a relative contraindication for azoles or polygenes due to hepatic or renal dysfunction, are scheduled to receive anidulafungin for one of the folowing specific indications:
- •need for primary antifungal prophylaxis in patients with AML/MDS during induction, reinduction or consolidation chemotherapy OR after allogenic HSCT with GvHD
- •need for secondary antifungal prophylaxis in patients with a history of a proven or probable invasive fungal infection who are expected to become neutropenic during induction, reinduction or consolidation chemotherapy
- •indication for treatment of proven, probable or possible fungal infection
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •absence of written informed consent
- •female patients who are pregnant or lactating
- •use of anidulafungin within 30 days prior to study
- •known hypersensitivity to anidulafungin
- •proven IFI with pathogen of known resistance to echinocandines
- •life expectancy less than 1 month
研究者
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