An Open-label, Randomized Study to Assess Inhibition of Spore Production in Patients With Clostridium Difficile Infections: Fidaxomicin Versus Vancomycin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool
研究概览
简要总结
The purpose of this study is to compare number of vegetative cells and spores in stool over time for fidaxomicin or vancomycin in patients diagnosed with their first episode of C. difficile infection.
详细描述
The purpose of this study is to:
- Compare quantitatively the number of vegetative cells in stool over time for fidaxomicin or vancomycin in patients diagnosed with their first episode of C. difficile infection
- Compare quantitatively the number of spores in the stool over time for patients presenting with their first episode of C. difficile infection having been treated with either fidaxomicin or vancomycin.
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
盲法说明
Open-label
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
- •18 years of age and above
- •First diagnosis of C. difficile infection
- •Treatment for C. difficile infection less than 24 hours
- •Female subjects must be nonpregnant, nonlactating, and either postmenopausal for at least 1 year, surgically sterile (i.e., documented tubal ligation or hysterectomy) for at least 90 days, abstinent, or agree to use 1 of the following forms of contraception from the time of signing the Informed Consent form (ICF) until 30 days after leaving the study site: a nonhormonal intrauterine device (IUD) with spermicide, female condom with spermicide, contraceptive sponge with spermicide, diaphragm with spermicide, cervical cap with spermicide, a male sexual partner who agrees to use a male condom with spermicide, or a sterile sexual partner.
排除标准
- •History of hypersensitivity to fidaxomicin or vancomycin
- •Pregnant or breast-feeding
- •Active treatment with other therapies with activity against C. difficile
- •Receiving any peristaltic agents
- •Medical history including ulcerative colitis or Chron's disease
- •Ordered to be nothing by mouth or cannot swallow the study medication
- •Participation in another clinical research study utilizing pharmacological treatment within 1 month or five half-lives of the medication whichever is longer
- •Any other reason felt by the investigator to potentially affect the outcomes of the study
研究组 & 干预措施
Fidaxomicin
Fidaxomicin 200mg by mouth every 12 hours for 10 days
干预措施: Fidaxomicin (Drug)
Vancomycin
Vancomycin 125mg by mouth every 6 hours for 10 days
干预措施: Vancomycin (Drug)
结局指标
主要结局
C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool
时间窗: day 10-13
The number and percentage of patients who achieved at least 2 log10 colony forming units (CFU)/g of stool reductions of Clostridium difficile spores from baseline by the end of therapy (days 10-13).
C. Difficile Vegetative Cell Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool
时间窗: day 10-13
The number and percentage of patients who achieved at least 2 log10 CFU/g of stool reductions of Clostridium difficile vegetative cells from baseline by the end of therapy (days 10-13)
次要结局
未报告次要终点