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临床试验/NCT03139253
NCT03139253Unknown4 期

Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment

Yanqing Li0 个研究点目标入组 120 人开始时间: 2017年5月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
120
主要终点
Eradication rate of AST guided triple therapy

研究概览

简要总结

Helicobacter pylori (H. pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H. pylori eradication is an effective approach to reduce the incidence of those pathologies.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consecutive patients who are 18-70 years old with persistent H. pylori infection after first or second line treatment attempts.

排除标准

  • Enable to undergo upper endoscopy;
  • Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
  • Known or suspected allergy to study medications;
  • Taking bismuth and antibiotics in the previous four weeks, or taking proton pump inhibitor and H2-receptor blockers in the previous two weeks;
  • Currently pregnant or lactating
  • Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

研究组 & 干预措施

clarithromycin susceptible

Experimental

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and clarithromycin.

Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI).

干预措施: amoxicillin (Drug)

clarithromycin susceptible

Experimental

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and clarithromycin.

Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI).

干预措施: clarithromycin (Drug)

clarithromycin susceptible

Experimental

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and clarithromycin.

Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI).

干预措施: Ilaprazole (Drug)

metronidazole susceptible

Experimental

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tinidazole.

干预措施: amoxicillin (Drug)

metronidazole susceptible

Experimental

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tinidazole.

干预措施: tinidazole (Drug)

metronidazole susceptible

Experimental

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tinidazole.

干预措施: Ilaprazole (Drug)

levofloxacin susceptible

Experimental

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and levofloxacin.

干预措施: amoxicillin (Drug)

levofloxacin susceptible

Experimental

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and levofloxacin.

干预措施: levofloxacin (Drug)

levofloxacin susceptible

Experimental

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and levofloxacin.

干预措施: Ilaprazole (Drug)

furazolidone susceptible

Experimental

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and furazolidone.

干预措施: amoxicillin (Drug)

furazolidone susceptible

Experimental

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and furazolidone.

干预措施: furazolidone (Drug)

furazolidone susceptible

Experimental

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and furazolidone.

干预措施: Ilaprazole (Drug)

tetracycline susceptible

Experimental

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tetracycline.

干预措施: amoxicillin (Drug)

tetracycline susceptible

Experimental

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tetracycline.

干预措施: tetracycline (Drug)

tetracycline susceptible

Experimental

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tetracycline.

干预措施: Ilaprazole (Drug)

结局指标

主要结局

Eradication rate of AST guided triple therapy

时间窗: 3 months

次要结局

  • the rate of good compliance (take pills more than 90%)(3 months)
  • the rate of adverse events happening(3 months)
  • the rate of improving dyspepsia symptoms after H. pylori eradication(3 months)

研究者

发起方
Yanqing Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yanqing Li

Vice president of Qilu Hospital

Shandong University

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