Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Eradication Rate (Participants Naive to Anti-H. Pylori Treatment)
研究概览
简要总结
This prospective controlled randomized open-label clinical trial is designed to determine the eradication rate of 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole regimen compared with 7-day standard triple therapy for adults infected with Helicobacter pylori in Eastern Taiwan.
详细描述
BACKGROUND:
The resistance rate of Helicobacter pylori (Hp) to amoxicillin and metronidazole therapy is significantly higher in Eastern Taiwan as compared to national and worldwide rates. The high resistance rate in this territory justified a search for a better eradication regimen for Hp infection.
AIM:
To evaluate the efficacy and tolerability of a combination therapeutic regimen of levofloxacin, amoxicillin/clavulanate and rabeprazole (LAcR) versus a conventional seven-day triple therapy with clarithromycin, amoxicillin and rabeprazole (CAR) for the eradication of Hp infection.
METHODS:
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient proved with infection of H. pylori in gastric mucosa
- •Patient with signed informed consent.
排除标准
- •woman in breast feeding or pregnancy.
- •allergy or severe adverse effects to drugs used in study.
- •severe complications of peptic ulcer disease (like perforation or obstruction).
- •patients with history of cancer or failure of major organs.
研究组 & 干预措施
Levofloxacin-Amoxicillin/clavulanate
7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
干预措施: Levofloxacin-Amox/clav. (Drug)
Clarithromycin-Amoxicillin
7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
干预措施: Clarithromycin-Amoxicillin (Drug)
结局指标
主要结局
Eradication Rate (Participants Naive to Anti-H. Pylori Treatment)
时间窗: 4 weeks after complete use of drug for treatment
A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment.
次要结局
- Eradication Rate of Participants Living in Rural Area.(4 weeks after complete use of drug for treatment)
研究者
Ming-Cheh Chen
Principal investigator
Buddhist Tzu Chi General Hospital