EUCTR2013-001448-75-Outside-EU/EEA进行中（未招募）不适用
A Phase 2A, Multi-Center, Open-Label, Uncontrolled Study toDetermine the Safety, Tolerability, and Pharmacokinetics of fidaxomicin Oral Suspension or Tablets in Pediatric Subjects With Clostridium difficile-associated Diarrhea (CDAD)
Optimer Pharmaceutical, Inc. (a Cubist company)0 个研究点目标入组 32 人开始时间: 2014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
- 入组人数
- 32
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
- •Subjects with CDAD as defined by:
- •- Presence of either toxin A or B (or both) of C. difficile in the stool within 48 hours of enrolment, and
- •- Subjects 2 to less than 18 years: diarrhea defined as a change in bowel habits with >3 unformed bowel movements in the 24 hours prior to enrollment, and
- •- subjects 6 to less than 24 months: > 3 episodes of watery diarrhea in the 24 hours prior to enrolment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 38
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Subjects with severe complicated CDAD including fulminant colitis or inflammatory bowel disease (ulcerative colitis or Crohns’ disease)
- •- Concurrent use of oral vancomycin or metronidazole or any other effective treatments for CDAD
研究者
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