Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Number of Participants With Recurrent C. Diff Infection at 90 Days
研究概览
简要总结
The study will compare the effectiveness of Bezlotoxumab in individuals with active C. diff ( Clostridium difficile) infection who are diagnosed with Inflammatory Bowel Disease.
详细描述
Bezlotoxumab is administered during a course of antibiotic therapy. The dose is administered as one time treatment. Patients will receive 10 mg/kg IV over 60 minutes as a single dose via central line.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •>18 years old
- •active CDI receiving therapy
- •diagnosis of IBD
- •and history of CDI.
排除标准
- •<18 years old
- •history of colectomy
- •history of preexisting congestive heart failure
- •pregnant or nursing women
- •past cardiac history.
研究组 & 干预措施
Open label
Single arm
干预措施: Bezlotoxumab (Biological)
结局指标
主要结局
Number of Participants With Recurrent C. Diff Infection at 90 Days
时间窗: 90 days
Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.
Number of Participants With Recurrent C. Diff Infection at 12 Months
时间窗: 12 months
Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.
Number of Participants With Recurrent C. Diff Infection at 24 Months
时间窗: 24 months
Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.
次要结局
- Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 90 Days(90 days)
- Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 12 Months(12 months)
- Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 24 Months(24 months)
- Quality of Life and Disease Activity Scores of Participants at Study Baseline(Index visit)
- Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 90 Days(90 Days)
- Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 12 Months(12 months)
- Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 24 Months(24 months)
- Rates of Health Care Utilization After Bezlotuxumab Infusion 90 Days(90 Days)
- Rates of Health Care Utilization After Bezlotuxumab Infusion 12 Months(12 months)
- Rates of Health Care Utilization After Bezlotuxumab Infusion 24 Months(24 months)
研究者
David Binion, MD
Professor
University of Pittsburgh