Levofloxacin and Bismuth-containing Therapy Versus Quadruple Therapy as Second-line Treatment of Resistant Helicobacter Pylori Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- eradication rate
研究概览
简要总结
To test the efficacy of 14 day levofloxacin and bismuth-containing second-line therapy for resistant Helicobacter pylori infection, to compare with the classical quadruple therapy.
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
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients had failed H.pylori therapies including clarithromycin, metronidazole and/or amoxicillin (if not allergic) before.
排除标准
- •patients less than 18 years old,
- •previous gastric surgery,
- •pregnancy,
- •lactation,
- •major systemic diseases,
- •administration of antibiotics,
- •antisecretory drugs in the preceding 8 weeks, or
- •allergy to any one of the medication used in the quadruple regimens.
研究组 & 干预措施
Levofloxacin-bismuth therapy
14 day levofloxacin and bismuth-containing therapy:PPI,bismuth, amoxicillin, levofloxacin
干预措施: Proton pump inhibitor (Drug)
Levofloxacin-bismuth therapy
14 day levofloxacin and bismuth-containing therapy:PPI,bismuth, amoxicillin, levofloxacin
干预措施: Bismuth subsalicylate (Drug)
Levofloxacin-bismuth therapy
14 day levofloxacin and bismuth-containing therapy:PPI,bismuth, amoxicillin, levofloxacin
干预措施: Amoxicillin (Drug)
Levofloxacin-bismuth therapy
14 day levofloxacin and bismuth-containing therapy:PPI,bismuth, amoxicillin, levofloxacin
干预措施: Levofloxacin (Drug)
classical quadruple therapy
14 day classical quadruple therapy:PPI,bismuth, metronidazole, tetracycline
干预措施: Proton pump inhibitor (Drug)
classical quadruple therapy
14 day classical quadruple therapy:PPI,bismuth, metronidazole, tetracycline
干预措施: Bismuth subsalicylate (Drug)
classical quadruple therapy
14 day classical quadruple therapy:PPI,bismuth, metronidazole, tetracycline
干预措施: Metronidazole (Drug)
classical quadruple therapy
14 day classical quadruple therapy:PPI,bismuth, metronidazole, tetracycline
干预措施: Tetracycline (Drug)
结局指标
主要结局
eradication rate
时间窗: 2 months
urease breath test
次要结局
未报告次要终点
研究者
Hong Lu, MD
Prof. of Medicine
Shanghai Jiao Tong University School of Medicine