Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy in the First-line Anti-H. Pylori Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- the eradication rate of Helicobacter pylori
研究概览
简要总结
- Compare the efficacies and safety of 14-day bismuth-amoxicillin-vonoprazan tiple therapy, 14-day vonoprazan dual therapy and 14-day rabeprazole triple therapy in the first-line treatment of H. pylori infection.
- To investigate the impacts of antibiotic resistance of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H. pylori treatments.
详细描述
For this multi-center, randomized, open-label, superiority trial, we will recruit 780 adult patients with H. pylori infection from ten medical centers or regional hospitals in Taiwan. Using a computer generated randomized sequence, we randomly allocate patients (1:1:1; block size of six) to either 14-day bismuth-amoxicillin-vonoprazan triple therapy, 14-day vonoprazan dual therapy, or 14-day rabeprazole-triple therapy. Patients are asked to return at the second week to assess drug adherence and adverse events. Post-treatment H. pylori status is assessed by 13C-urea breath test at week 6. Participants with failure of H. pylori eradication will randomly receive either 14-day vonoprazan-based or 14-day esomeprazole-based bismuth quadruple therapy. Finally, the rates of eradication and adverse events will be compared between groups by chi-square test. Additionally, the effects of antibiotic resistances of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of above first-line and second-line anti-H. pylori treatments are assessed by multivariate analysis.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) At least 18 years old. (2) Subjects infected with Helicobacter pylori.
排除标准
- •Those who have ever received Helicobacter pylori sterilization treatment.
- •Those who are allergic to the drugs used in this research.
- •Those who have had stomach surgery.
- •Those with severe liver cirrhosis or uremia or malignant tumors.
- •Women who are pregnant or breastfeeding.
研究组 & 干预措施
bismuth-amoxicillin-vonoprazan triple therapy
vonoprazan 20mg twice a day + amoxicillin 750mg four times a day + tripotassium dicitrate bismuthate 300mg four times a day
干预措施: vonoprazan, amoxicillin, tripotassium dicitrate bismuthate (Drug)
vonoprazan-amoxicillin dual therapy
vonoprazan 20mg twice a day + amoxicillin 750mg,Four times a day
干预措施: vonoprazan, amoxicillin (Drug)
proton pump inhibitor-based standard triple therapy
rabeprazole 20mg twice a day + amoxicillin 1gm twice a day + clarithromycin 500mg twice a day
干预措施: rabeprazole, amoxicillin, clarithromycin (Drug)
结局指标
主要结局
the eradication rate of Helicobacter pylori
时间窗: 8 week after finishing study drugs
evalute eradication outcome by 13C urea breath test
次要结局
- genotype analysis(1 day)
研究者
DENG-CHYANG WU
clinical professor
Kaohsiung Medical University
