A Prospective Randomized Trial of Levofloxacin-amoxicillin Triple Therapy vs. Levofloxacin-tetracycline Quadruple Therapy in Second-line Helicobacter Pylori Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Number of Participants in Which H. Pylori Was Eradicated
研究概览
简要总结
From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.
详细描述
The H pylori-infected adult patients with failure of standard triple therapy and H pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly assigned to either EAL (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.) or EBTL (esomeprazole 40 mg b.d., bismuth 500 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.) therapy for 10 days. Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests is performed at six weeks after the end of anti-H pylori 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •positive results of both rapid urease test and histology,
- •a positive result of urea breath test,
- •or a positive result of culture.
排除标准
- •ingestion of antibiotics, bismuth, or proton pump inhibitor（PPI）within the prior 4 weeks,
- •patients with allergic history to the medications used,
- •patients with previous gastric surgery,
- •the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
- •pregnant women
研究组 & 干预措施
esomeprazole+amox+levo
esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.
干预措施: esomeprazole+amox+levo (Drug)
esomeprazole+bismuth+tetra+levo
esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.
干预措施: esomeprazole+bismuth+tetra+levo (Drug)
结局指标
主要结局
Number of Participants in Which H. Pylori Was Eradicated
时间窗: six weeks after the end of anti-H pylori therapy.
Number of participants with negative H pylori status in follow-up tests as a measure of successful eradication
次要结局
未报告次要终点
研究者
Ping-I (William) Hsu, M.D.
Professor
Kaohsiung Veterans General Hospital.