A Phase 2A, Multi-Center, Open-Label, Uncontrolled Study to Determine the Safety, Tolerability, and Pharmacokinetics of Fidaxomicin Oral Suspension or Tablets in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 主要终点
- Number of Participants With Adverse Events.
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 6 months to 17 years 11 months of age, inclusive;
- •Female subjects of childbearing potential must use adequate contraception
- •Diagnosed with CDAD
排除标准
- •Concurrent use of oral vancomycin or metronidazole or any other effective treatments for CDAD
- •Fulminant colitis
- •History of inflammatory bowel disease
- •Pregnant or breast-feeding
- •Need for concurrent use of some P-glycoprotein inhibitors during therapy
研究组 & 干预措施
fidaxomicin
干预措施: fidaxomicin (Drug)
结局指标
主要结局
Number of Participants With Adverse Events.
时间窗: Enrollment through end of study (Day 38-41)
Number of participants with adverse events, as categorized by MedDRA.
Investigate Concentrations of Fidaxomicin in Plasma Samples.
时间窗: 3-5 hours after administration
3-5 hour plasma levels of fidaxomicin (mean)
Investigate Concentrations of Fidaxomicin in Fecal Samples.
时间窗: End of Therapy; Day 10-11
End of therapy fecal levels of fidaxomicin (mean)
Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples.
时间窗: 3-5 hours after administration
3-5 hour plasma levels of OP-1118 (mean)
Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples.
时间窗: End of Therapy; Day 10-11
End of therapy fecal levels of OP-1118 (mean)
次要结局
- Evaluate the Clinical Outcome by Assessment of Clinical Response.(Day 10)
- Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response.(28 days post-treatment)