EUCTR2014-003002-32-AT进行中（未招募）1 期
Open label study to evaluate the pharmacokinetics of fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects with Clostridium difficile Infection (CDI) - PROFILE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
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
- •? Subject is aged at least 18
- •? Confirmed diagnosis or history of IBD for at least 3 months
- •? CDI confirmed positive according to local standard testing for the presence of C. difficile within 48 hr prior to enrolment.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Subject has received more than one day of dosing of any CDI therapy within the 48 hrs prior to enrolment.
- •Presence of an ostomy or short bowel syndrome
- •Subject has a current diagnosis of toxic megacolon
- •Subject has previously participated in a CDI vaccine study
- •Subject has hypersensitivity to fidaxomicin or any of its components
研究者
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