NCT02092935已完成2 期
A Phase II, Randomized, Double-Blind, Active-Controlled Clinical Study to Investigate the Efficacy and Safety of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Evaluate the clinical outcome by assessment of sustained clinical response
研究概览
简要总结
The purpose of this research study is to evaluate the safety and effectiveness of a new oral antibiotic called SMT19969 in treating C. difficile Infection (CDI).
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Clinical diagnosis of CDAD plus laboratory diagnostic test
- •No more than 24 hrs antimicrobial treatment for current CDAD episode
- •No more than 3 episodes of CDAD in prior 12 months
- •No previous episode of CDAD within 30 days of study enrollment
- •Female subjects of childbearing potential must use adequate contraception
排除标准
- •Life-threatening or fulminant colitis
- •Concurrent use of antibiotics or any other treatments for CDAD
- •History of inflammatory bowel disease (ulcerative colitis, Crohn's disease)
- •Participation in other Clinical research studies within one month of screening
研究组 & 干预措施
SMT19969
Experimental
200 mg capsule of SMT19969 twice a day for 10 days with alternating 200 mg placebo twice a day
干预措施: SMT19969 (Drug)
Vancomycin
Active Comparator
125 mg capsule four times a day for 10 days
干预措施: Vancomycin (Drug)
结局指标
主要结局
Evaluate the clinical outcome by assessment of sustained clinical response
时间窗: 30 days post End of Therapy
Sustained clinical response is defined as clinical cure at the Test of Cure Visit (Day 12) and no recurrence of CDAD within 30 days of End of Therapy
次要结局
- Plasma and faecal concentrations of SMT19969(40 Days)
- To assess the safety and tolerability of SMT19969 compared with vancomycin(40 days)
研究者
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