Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- The Incidence of Clostridium Difficile Diarrhea in Both Study Groups at 30 Days Post Broad Spectrum Antibiotic Use.
研究概览
简要总结
The purpose of this study is to test if metronidazole prophylaxis is effective in decreasing the incidence of hospital induced Clostridium Difficile diarrhea among patients at high risk for this infection.
详细描述
Clostridium Difficile infection or C. Diff (CDI) is an infection that causes severe diarrhea. Risk factors for this infection include hospitalization, the use of antibiotics, along with medications that decrease the acid in the stomach. This infection leads to a disease which is difficult to treat and can cause serious complications including death in rare cases. This infection also increases medical costs by prolonging hospital stays.
Metronidazole (known by the brand name Flagyl) is an antibiotic that has been available for decades and has been used to treat this disease. Flagyl is approved by the Food and Drug Administration for the treatment of C. diff infection. Recent research by the investigators group has shown that hospitalized patients who took Flagyl had a decreased chance of getting C. Diff infection. However, high quality studies are needed to better evaluate whether the investigators can prevent C. Diff infection in high risk patients with the use of Flagyl.
The purpose of this study is to assess if metronidazole prophylaxis is effective in decreasing the incidence of hospital induced Clostridium Difficile diarrhea among inpatients at high risk for this infection.
High risk patient population are as defined below: taking a broad spectrum antibiotics (piperacillin/tazobactam-Zosyn; Ciprofloxacin).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients >55
- •Proton Pump inhibitor / Histamine-2 Blocker
- •On broad spectrum antibiotics (Zosyn and/or Ciprofloxacin). These two antibiotics are selected based on current hospital formulary/use
- •Anticipated hospital stay >48 hours
- •Mental capacity (able to give informed written consent).
排除标准
- •Admission for CDI
- •Existing diarrhea at admission
- •Passed prophylactic window (>48 hours on broad spectrum antibiotics)
- •Unable to take PO at the time of evaluation for study entry
- •No more than 14 days of broad spectrum antibiotics anticipated
- •Medications with serious interactions/contraindications to that would be taken together with metronidazole (ex. Warfarin, disulfiram, phenytoin, calcineurin inhibitors)
- •Inflammatory Bowel Disease
- •Admission for colonic bowel surgery or h/o total/Subtotal colectomy)
- •Mortality expected <7days
- •Previous CDI in the past 6 months
- •Intensive care admission due to the difficulty of monitoring them
- •Allergy to Metronidazole or other Antibiotics in protocol
- •Patients with neuropathy
- •History of heavy ethyl alcohol intake(greater than 3 drinks daily) or intake in past 24 hours,Solid organ transplant.
研究组 & 干预措施
Metronidazole
Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days
干预措施: Metronidazole (Drug)
Placebo
Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
The Incidence of Clostridium Difficile Diarrhea in Both Study Groups at 30 Days Post Broad Spectrum Antibiotic Use.
时间窗: 30 days
次要结局
- Determine Differences in Clostridium Difficile Diarrhea Incidence Between Patients on Piperacillin/Tazobactam vs. Patients on Ciprofloxacin.(30 days)
研究者
Alison Schneider
M.D
Cleveland Clinic Florida