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临床试验/NCT04006340
NCT04006340Unknown不适用

Comparison of Empirical and Genotypic Resistance Guided Tailored Therapy for Helicobacter Pylori Infection

Seoul National University Hospital2 个研究点 分布在 2 个国家目标入组 62 人开始时间: 2019年1月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
62
试验地点
2
主要终点
Eradication rate

研究概览

简要总结

We aimed to compare the efficacy of genotypic resistance-guided tailored therapy vs empirical therapy for eradication of Helicobacter pylori (H. pylori) infection in randomized controlled trials.

详细描述

Empirical therapy is conventional triple therapy (proton pump inhibitor (PPI) standard dose, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days). Genotypic resistance-guided tailored therapy is the method which is chosen by DPO-PCR test. While the patients who have positive result of clarithromycin resistance receive the quadruple therapy(PPI standard dose, bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days), clarithromycin susceptible patients receive the triple therapy.

H. pylori is difficult to cultivate, cultivation of H. pylori and minimum inhibitory concentration test as a resistance test method are very difficult and take a long time. Recently, tailored treatment based on clarithromycin susceptibility has been proposed by dual-priming oligonucleotide-based multiplex (DPO)-PCR test. This is a method to confirm the mutation of A2142G and A2143G by PCR, which are known to be highly related to the resistance of clarithromycin 23S rRNA point mutation. This test is performed only by gastric biopsy. The examination time is also short as several hours, and sensitivity and specificity are about 80-85%.

Antibiotic resistance of H. pylori, especially clarithromycin resistance, is a cause of major failure of its eradication, and Korea 's clarithromycin resistance rate is reported to be about 37%. The eradication rate of standard triple therapy reported in Korea is also unsatisfactory as antibiotic resistance rate of H. pylori increases. The ideal eradication rate for H. pylori is approximately 90%, but in the meta-analysis of the recently reported primary eradication, the overall eradication rate was 74.6% in the intention to treat 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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with H. pylori who had undergone endoscopic resection for gastric neoplasm
  • Patients with H. pylori who had diagnosed at peptic ulcer disease, MALT lymphoma

排除标准

  • history of gastrectomy
  • patients aged younger than 20 years or older than 80 years
  • history of H. pylori eradication therapies or other antibiotics therapy within a month
  • previous allergic reaction to the study drugs (amoxicillin, clarithromycin, metronidazole, tetracycline, and esomeprazole)
  • contraindication to treatment drugs
  • pregnant or lactating women
  • severe concurrent illness

结局指标

主要结局

Eradication rate

时间窗: 13C-UBT at least 4 weeks after completion of treatment

Eradication rate of H. pylori infection

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

Soo-Jeong Cho

Clinical Associate Professor

Seoul National University Hospital

研究点 (2)

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Empirical vs Tailored Therapy for H. Pylori Infection | 临床试验