Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection - a Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 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 TL quadruple therapy (esomeprazole-bismuth-tetracycline-levofloxacin regimen) or AL quadruple therapy (esomeprazole-bismuth-amoxicillin-levofloxacin regimen) 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
- •Consecutive H pylori-infected outpatients, at least 20 years of age with failure of first-line eradication treatments (standard triple, non-bismuth quadruple and bismuth quadruple therapies)
排除标准
- •previous allergic reactions to the study medications,
- •history of gastrectomy,
- •use of antibiotics within the previous 4 weeks,
- •pregnant or lactating women,
- •coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia, and malignancy).
研究组 & 干预措施
10d TL quadruple therapy
esomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, tetracycline 500 mg and metronidazole 250 mg q.i.d. for 10 days
干预措施: 10d TL quadruple therapy (Drug)
10d AL quadruple therapy
esomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, amoxicillin 500 mg and metronidazole 250 mg q.i.d. for 10 days
干预措施: 10d AL quadruple therapy (Drug)
结局指标
主要结局
Number of Participants in Which H. Pylori Was Eradicated
时间窗: sixth week after the end of anti- H. pylori therapy
To assess eradication efficacy,repeated endoscopy with rapid urease test, histological
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.