Comparison of 14-day Sequential and Hybrid Therapies for H Pylori Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 240
- 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
Primary: To evaluate efficacy of 14 day 2-phase sequential therapy given in two forms. One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. The alternate will be similar with the exception that the amoxicillin will be continued throughout the 14 days. The secondary endpoint is to evaluate the effectiveness of therapy in relation to antibiotic resistance.
详细描述
The purpose of this study is to test whether the 14-day sequential therapy ( esomeprazole plus amoxicillin dual therapy for 7 days followed by triple therapy with esomeprazole, clarithromycin, and metronidazole for 7 days) or 14-day hybird therapy (esomeprazole plus amoxicillin dual therapy for 7 days followed by quadruple therapy with esomeprazole, amoxicillin, clarithromycin, and metronidazole for 7 days) can achieve an eradication rate equal to or more than 95%.
A total of 240 subjects will be asked to participate in this study.
H. pylori-infected patients are randomized to either a 14-day sequential therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days) or a hybrid therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days).
Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the end of anti-H. pylori therapy. The eradication rates of the two study groups will be compared.
A successful regimen is defined as a regimen achieving an eradication rate equal to or more than 95%.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 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 18 years of age, with endoscopically proven peptic ulcer diseases or gastritis
排除标准
- •previous H. pylori-eradication therapy
- •ingestion of antibiotics, bismuth, or PPIs 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
14-day sequential treatment
One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
干预措施: 14-day sequential treatment (Drug)
14-day hybrid treatment
esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
干预措施: 14-day hybrid treatment (Drug)
结局指标
主要结局
Number of Participants in Which H. Pylori Was Eradicated
时间窗: Dec 2010
evaluate eradication outcome by endoscopy with urease test or urea breath test
次要结局
- Adverse Events(Dec 2010)
- Compliance Rate(Dec 2010)
研究者
Ping-I (William) Hsu, M.D.
Professor
Kaohsiung Veterans General Hospital.