Fidaxomicin Versus Standard of Care Therapy in Solid Organ Transplant Recipients With Clostridium Difficile Infection
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- The proportion of patients with a sustained clinical response (SCR), defined as clinical cure with no recurrence.
研究概览
简要总结
A prospective study to assess the efficacy and safety of fidaxomicin in Solid Organ Transplant (SOT) recipients (heart, lung, kidney, liver, kidney-pancreas, and pancreas) with a first-episode of Clostridium difficile infection (CDI).
详细描述
Patients will be treated with fidaxomicin 200 mg PO twice daily for 10 days. The rate of sustained clinical response (SCR; cure without recurrence at 30 days) will be assessed and compared to a historical cohort of SOT recipients who received standard of care therapy for CDI at our institution. The data for the historical control group will be collected under a separate IRB-approved protocol. Standard of care therapy will be considered oral or intravenous metronidazole and / or oral vancomycin. The study will be powered to show non-inferiority of fidaxomicin compared to standard of care treatment in SOT recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or greater and up 85 years
- •SOT recipient (lung, heart, kidney, liver, kidney-pancreas, pancreas)
- •First episode of CDI
排除标准
- •Receiving additional therapies with activity again C. difficile (oral bacitracin, fusidic acid, and/or rifaximin)
- •Toxic megacolon
- •Ileus or significant abdominal distension
- •Hypotension with vasopressor requirement
- •History of inflammatory bowel disease
- •Pregnancy
- •Decisionally challenged
- •Prisoners
- •>4 doses of metronidazole for the treatment of C. difficile in the previous 7 days
- •>4 doses of oral vancomycin in the previous 7 days
研究组 & 干预措施
SOT Recipients
SOT recipients (heart, lung, kidney, liver, kidney-pancreas, and pancreas) with a first-episode of CDI. Patients will be treated with fidaxomicin 200 mg PO twice daily for 10 days. The rate of sustained clinical response (SCR; cure without recurrence at 30 days) will be assessed.
干预措施: fidaxomicin (Drug)
结局指标
主要结局
The proportion of patients with a sustained clinical response (SCR), defined as clinical cure with no recurrence.
时间窗: 30 days
次要结局
未报告次要终点