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临床试验/NCT03431688
NCT03431688已完成不适用

Efficacy Comparison of Metronidazole-based Triple and Bismuth-based Quadruple Therapy for Clarithromycin Resistant-Helicobacter Pylori Infection: Randomized Controlled Trial

Kangdong Sacred Heart Hospital1 个研究点 分布在 1 个国家目标入组 782 人开始时间: 2018年10月1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
已完成
入组人数
782
试验地点
1
主要终点
H. pylori eradication rate

研究概览

简要总结

Clarithromycin-resistant H. pylori is the main cause of H. pylori eradication failure. Tailored therapy on the basis of detection of a clarithromycin resistance mutation by PCR has been studied recently, however, there have been few studies comparing treatment regimen in patient with clarithromycin-resistant H. pylori. We used sequencing-based clarithromycin resistance mutation and aimed to compare PAM (proton pump inhibitor, amoxicilline, metronidazole) regimen and PBMT (proton pump inhibitor, bismuth, metronidazole, tetracyclin) regimen in patient with clarithromycin-resistant H. pylori.

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 (Participant)

入排标准

年龄范围
19 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • peptic ulcer disease
  • H. pylori gastritis
  • low grade MALT lymphoma

排除标准

  • history of gastric cancer surgery
  • severe comorbidity (ESRD, LC)
  • hypersensitivity to drug
  • pregnancy

研究组 & 干预措施

PAM

Active Comparator

treatment with PPI, metonidazole, amoxicillin

干预措施: PAM (Drug)

PBMT

Active Comparator

treatment with PPI, metonidazole, bismuth, tetracyclin

干预措施: PBMT (Drug)

结局指标

主要结局

H. pylori eradication rate

时间窗: 14 days

H. pylori eradication rate

次要结局

未报告次要终点

研究者

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

Shin, Woon Geon

Woon Geon Shin

Kangdong Sacred Heart Hospital

研究点 (1)

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