跳至主要内容
临床试验/NCT06349486
NCT06349486招募中不适用

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

Kaohsiung Medical University1 个研究点 分布在 1 个国家目标入组 390 人开始时间: 2023年11月28日最近更新:
适应症
干预措施
相关药物

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

  1. 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.
  2. 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

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

DENG-CHYANG WU

clinical professor

Kaohsiung Medical University

研究点 (1)

Loading locations...

相似试验