跳至主要内容
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)

Loading locations...

相似试验

Development of Treatment Algorithm for Eradication... | 临床试验