NCT02784002已完成2 期
A Phase II, Randomized, Open-Label, Active-Controlled Clinical Study to Investigate the Safety and Efficacy of SMT19969 (200mg BID) for 10 Days Compared With Fidaxomicin (200 mg BID) for 10 Days for the Treatment of Clostridium Difficile Infection (CDI)
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
- 27
- 试验地点
- 16
- 主要终点
- Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs) to evaluate safety and tolerability
研究概览
简要总结
The purpose of this research study is to evaluate the safety and effectiveness of Ridinilazole (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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent
- •Clinical diagnosis of CDI plus laboratory diagnostic test
- •No more than 30 hours antimicrobial treatment for current CDI episode
- •Female subjects of childbearing potential must use adequate contraception
排除标准
- •Life-threatening or fulminant CDI
- •Subjects with 2 or more episodes of CDI in the previous year
- •Females who are pregnant or breastfeeding
- •History of inflammatory bowel disease
- •Co-administration of potent P-glycoprotein inhibitors
- •Participation in other Clinical research studies within one month of screening
- •Subjects that the Investigator feels are inappropriate for the study
研究组 & 干预措施
Ridinilazole (SMT19969)
Experimental
200 mg capsule of Ridinilazole (SMT19969) twice a day for 10 days
干预措施: Ridinilazole (Drug)
Fidaxomicin
Active Comparator
200 mg tablet of Fidaxomicin twice a day for 10 days
干预措施: Fidaxomicin (Drug)
结局指标
主要结局
Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs) to evaluate safety and tolerability
时间窗: 30 days post End of Therapy
次要结局
- To assess the pharmacokinetics of SMT19969 in patients with CDI by measuring the plasma, urine and fecal concentrations of SMT19969(12 days)
- Measure sustained clinical response (SCR) rates(40 days)
- Measure clinical cure rates at the Test of Cure (TOC) visit(12 days)
- To assess the qualitative and quantitative effect on the bowel flora of each subject using 16S ribosomal RNA sequencing, metagenomics and bioinformatic techniques(40 days)
研究者
研究点 (16)
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