A Double-Blind Study to Compare the Safety and Efficacy of PAR-101 to Vancomycin in Subjects With Clostridium Difficile-Associated Diarrhea (CDAD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 535
- 主要终点
- Cure Rate at End of Therapy
研究概览
简要总结
This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
详细描述
The primary objective of this pivotal study is to investigate the safety and efficacy of PAR-101/OPT-80 versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD). The cure rates at end of therapy and recurrence rates will be evaluated and compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males/females with CDAD
- •Females must use adequate contraception
- •Signed informed consent
排除标准
- •Life-threatening CDAD
- •Toxic megacolon
- •Concurrent use of diarrheal agents
- •Participation in other trials
研究组 & 干预措施
1
Vancomycin
干预措施: Vancomycin (Drug)
2
PAR-101/OPT-80
干预措施: PAR-101/OPT-80 (Drug)
结局指标
主要结局
Cure Rate at End of Therapy
时间窗: Study day 10 (+/- 2 days)
Percentage of subjects with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication.
次要结局
- Global Cure(End of Study)
- Recurrence(Study days 11-40)