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临床试验/NCT02759029
NCT02759029Unknown不适用

Development of Treatment Algorithm for Eradication of Helicobacter Pylori Based on Antibiotic Susceptibility Test

Gangnam Severance Hospital1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2016年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
123
试验地点
1
主要终点
eradication rate of Helicobacter pylori

研究概览

简要总结

Helicobacter pylori eradication (H. pylori) rates with clarithromycin-based triple therapy are declining, and an alternative strategy is needed urgently. The investigators sought to compare the efficacy of pretreatment antimicrobial susceptibility-guided vs. clarithromycin-based triple therapy vs. concomitant therapy for H. pylori eradication in a region with high rates of multiple drug resistance.

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • positive results of rapid urease test

排除标准

  • liver cirrhosis,
  • chronic kidney disease,
  • bleeding tendency,
  • allergy to antibiotics

研究组 & 干预措施

Susceptibility-guided group

Active Comparator

Drugs according to antimicrobial susceptibility-guided treatment

干预措施: eradication of Helicobacter pylori (Drug)

triple therapy group

Sham Comparator

Drugs - Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk

干预措施: eradication of Helicobacter pylori (Drug)

concomitant therapy group

Sham Comparator

Drugs - Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk Metronidazole 500mg, PO, BID, 1wk

干预措施: eradication of Helicobacter pylori (Drug)

结局指标

主要结局

eradication rate of Helicobacter pylori

时间窗: the H. pylori status was checked 4 weeks aft er the end of treatment using the 13 C-urea breath test.

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

Jie hyun Kim

Associate Professor

Gangnam Severance Hospital

研究点 (1)

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