Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Triple Therapy as Second Line Therapy for Refractory Helicobacter Pylori Infection- A Multi-center Randomized Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 600
- 试验地点
- 9
- 主要终点
- Eradication rate in the second line therapy
研究概览
简要总结
To compare the efficacy and tolerability of levofloxacin-based sequential therapy and triple therapy in the second line therapy for those who fail from one eradication therapy
详细描述
About 600 patients who failed from first line triple therapy or sequential therapy will be eligible in this multicenter randomized comparative trial. Eligible patients will be randomized to receive either (1) levofloxacin-based sequential therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g for the first 5 days, followed by lansoprazole 30mg, levofloxacin 250mg, and metronidazole 500mg for another 5 days (all given twice daily)〕or (2) levofloxacin-based triple therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)〕. Eradication will be confirmed with 13C-Urea Breath Test 6 weeks after 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •H. pylori infected patients who failed from first line therapy will be eligible in this study
排除标准
- •Patients were excluded from the study if any one of the following criteria was present:
- •children and teenagers aged less than 20 years,
- •history of gastrectomy,
- •gastric malignancy, including adenocarcinoma and lymphoma,
- •previous allergic reaction to antibiotics (amoxicillin, metronidazole, levofloxacin) and PPI (lansoprazole),
- •contraindication to treatment drugs,
- •pregnant or lactating women, or
- •severe concurrent disease
研究组 & 干预措施
levofloxacin-based sequential therapy
levofloxacin-based sequential therapy
干预措施: levofloxacin-based sequential therapy (Drug)
levofloxacin-based triple therapy
levofloxacin-based triple therapy for 10 days
干预措施: levofloxacin-based triple therapy for 10 days (Drug)
结局指标
主要结局
Eradication rate in the second line therapy
时间窗: 6 weeks
Assessed by UBT
次要结局
- Incidence of adverse effect(2 weeks)
研究者
National Taiwan University Hospital
National Taiwan University Hospital
National Taiwan University Hospital