NCT02011841撤回3 期
Rifaximin for the Secondary Prevention of Spontaneous Bacterial Peritonitis Recurrence in Cirrhotic Patients: A Prospective, Multicenter, Randomized, Open-label, Controlled Phase III Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The recurrence rate of spontaneous bacterial peritonitis
研究概览
简要总结
The aim of this study is to evaluate whether long-term rifaximin administration reduces spontaneous bacterial peritonitis recurrence rate in cirrhotic patients.
详细描述
- Rifaximin is an antibiotic with a broad-spectrum activity against gram-positive and gram-negative microorganisms, both aerobes and anaerobes within the gastrointestinal tract. The main advantage of rifaximin is that it is poorly absorbable, which minimizes the antimicrobial resistance and adverse events and renders the drug safe in all patient populations. In addition, rifaximin has a better activity against gram-positive organisms than norfloxacin.
- The appreciation of the potential role of enteric flora in the pathogenesis of several gastrointestinal diseases has broadened the clinical use of rifaximin, which is now used for hepatic encephalopathy, small intestine bacterial overgrowth, inflammatory bowel disease, and Clostridium difficile infection. Theoretically, by reducing the total number of the gut bacteria, rifaximin could also be used to achieve intestinal decontamination in patients with liver cirrhosis and ascites, thus preventing spontaneous bacterial peritonitis.
- A small retrospective study concluded that rifaximin suppresses intestinal bacterial overgrowth, bacterial translocation in cirrhotic patients with ascites with no history of previous spontaneous bacterial peritonitis episodes. Prospective clinical trials are warranted to evaluate the role of rifaximin for prevention of spontaneous bacterial peritonitis recurrence in cirrhotic patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with cirrhosis based on clinical, biochemical, ultrasonographic and/or histological criteria
- •Patients who had recovered from an episode of spontaneous bacterial peritonitis
- •Age > 18 and <80 years
排除标准
- •Decompensated cirrhotic patients with
- •serum bilirubin > 3.2 mg/dL
- •prothrombin time < 25%
- •serum creatinine > 3 mg/dL
- •Active gastrointestinal bleeding
- •Hepatic encephalopathy > grade 2
- •Patients who have clinical, biochemical or radiological data suggesting hepatocellular carcinoma
研究组 & 干预措施
Rifaximin group
Experimental
Rifaximin 1200 mg/day orally for 6 months
干预措施: Rifaximin (Drug)
Control group
Active Comparator
Ciprofloxacin 500 mg/day orally for 6 months
干预措施: Ciprofloxacin (Drug)
结局指标
主要结局
The recurrence rate of spontaneous bacterial peritonitis
时间窗: every 4 weeks, up to 24 weeks
The proportion of patients who recurred spontaneous bacterial peritonitis.
次要结局
- Causative bacteria of recurrent spontaneous bacterial peritonitis(every 4 weeks, up to 24 weeks)
- Infections other than spontaneous bacterial peritonitis(every 4 weeks, up to 24 weeks)
- The recurrence of culture-negative spontaneous bacterial peritonitis(every 4 weeks, up to 24 weeks)
- Change of gut microbiota(at baseline, week 12)
- mortality(up to 24 weeks)
研究者
Jeong-Hoon Lee
Assistant Professor
Seoul National University Hospital
研究点 (1)
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