Comparison of 12-day Reverse Hybrid Therapy and 12-day Standard Triple Therapy for Helicobacter Pylori Infection - a Randomized Controlled Trial (REHYTRI Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 440
- 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
Reverse hybrid therapy is a one-step two-phase treatment for Helicobacter pylori infection with less cost than standard triple therapy. Whether reverse hybrid therapy can replace standard triple therapy as the recommended first-line treatment is unknown. The investigators compared the efficacy of 12-day reverse hybrid therapy and 12-day standard triple therapy in first-line treatment.
详细描述
For this multicentre, single-blind, and randomized-controlled trial (REHYTRI study), the investigator recruited patients with H pylori infection. Using a computer-generated randomization sequence, the investigator randomly allocated patients to either 12-day reverse hybrid therapy (pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg, amoxicillin 1 g for another 5 days; with all drugs given twice daily) or a 12-day standard triple therapy (pantoprazole 40 mg, clarithromycin 500 mg, amoxicillin 1 g for 12 days; with all drugs given twice daily) at a 1:1 ratio. Our primary outcome was the eradication rate by intention-to-treat and per-protocol analyses.
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 (Investigator)
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
- •Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis
排除标准
- •previous H pylori-eradication therapy
- •ingestion of antibiotics or bismuth 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
Reverse hybrid therapy
pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily
干预措施: Reverse hybrid therapy (Drug)
Standard triple therapy
pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily
干预措施: Standard triple therapy (Drug)
结局指标
主要结局
Number of Participants in Which H. Pylori Was Eradicated
时间窗: at the 6th week after the end of anti- H. pylori therapy
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test
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.