Helicobacter Pylori Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 424
- 试验地点
- 1
- 主要终点
- eradication rate of H. pylori
研究概览
简要总结
The increase of antibiotic resistance to H. pylori causes failure of treatment. Furazolidone, amoxicillin and tetracycline are good candidates for rescue therapy since resistance to these three antimicrobials was rare. It is necessary to assess the efficacy and safety of these four bismuth-containing quadruple regimens with above antibiotics as empirical rescue therapies for H. pylori eradication.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •H. pylori -positive patients with functional dyspepsia and scarred peptic ulcers who had previously failed one or more eradication regimens containing clarithromycin, metronidazole and/or amoxicillin.
排除标准
- •less than 18 years old, never receiving eradication treatment before, with previous gastric surgery, pregnancy, lactation, major systemic diseases, administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks
研究组 & 干预措施
tetracycline/furazolidone
one of the four empirical rescue therapies
干预措施: Bismuth (Drug)
tetracycline/furazolidone
one of the four empirical rescue therapies
干预措施: Tetracycline (Drug)
tetracycline/furazolidone
one of the four empirical rescue therapies
干预措施: Proton Pump Inhibitor (Drug)
tetracycline/furazolidone
one of the four empirical rescue therapies
干预措施: Furazolidone (Drug)
amoxicillin/tetracycline
one of the four empirical rescue therapies
干预措施: Proton Pump Inhibitor (Drug)
amoxicillin/tetracycline
one of the four empirical rescue therapies
干预措施: Bismuth (Drug)
amoxicillin/tetracycline
one of the four empirical rescue therapies
干预措施: Tetracycline (Drug)
amoxicillin/tetracycline
one of the four empirical rescue therapies
干预措施: Amoxicillin (Drug)
amoxicillin/furazolidone
one of the four empirical rescue therapies
干预措施: Proton Pump Inhibitor (Drug)
amoxicillin/furazolidone
one of the four empirical rescue therapies
干预措施: Bismuth (Drug)
amoxicillin/furazolidone
one of the four empirical rescue therapies
干预措施: Furazolidone (Drug)
amoxicillin/furazolidone
one of the four empirical rescue therapies
干预措施: Amoxicillin (Drug)
tetracycline /metronidazole
Classical rescue therapy
干预措施: Proton Pump Inhibitor (Drug)
tetracycline /metronidazole
Classical rescue therapy
干预措施: Bismuth (Drug)
tetracycline /metronidazole
Classical rescue therapy
干预措施: Metronidazole (Drug)
tetracycline /metronidazole
Classical rescue therapy
干预措施: Tetracycline (Drug)
结局指标
主要结局
eradication rate of H. pylori
时间窗: 2 months
次要结局
未报告次要终点
研究者
Dr. HONG LU
professor of GI Division, Renji Hospital
Shanghai Jiao Tong University School of Medicine