NCT01533844终止不适用
An Observational, Non-interventional Study to Determine the Role of Clostridium Difficile in the Pathogenesis of Disease Observed in Neonates and to Investigate the Feasibility of a Potential Study to Evaluate Safety, Efficacy and Pharmacokinetics of Fidaxomicin Oral Suspension in Neonates With Clostridium Difficile Associated Disease (CDAD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 9
- 主要终点
- To determine the feasibility of a potential interventional study with fidaxomicin
研究概览
简要总结
The objective of this multi-center, prospective observational study is to determine the feasibility of a potential interventional study with fidaxomicin. The incidence and clinical aspects of Clostridium difficile infection (CDI) in neonates will be determined, and it will be assessed whether a subgroup can be identified where treatment with fidaxomicin therapy might improve outcome.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 27 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is suffering from diarrhea or other signs or symptoms consistent with CDAD (as described in section 5.2.3)
- •Presence of either toxin A or B (or both) of C. difficile in the stool within 24 hours prior to enrollment using the C. difficile Quik Chek Complete® diagnostic test, provided by the sponsor
排除标准
- •Subject will be excluded from participation if any of the following apply:
- •Preterm neonates
- •Negative C. difficile toxin test
结局指标
主要结局
To determine the feasibility of a potential interventional study with fidaxomicin
时间窗: 40 days
The incidence and clinical aspects of clostridium difficile infection (CDI) in neonates will be determined, and it will be assessed whether a subgroup can be identified where treatment with fidaxomicin therapy might improve outcome.
次要结局
未报告次要终点
研究者
研究点 (9)
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