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Clinical Trials/NCT03139253
NCT03139253
Unknown
Phase 4

Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment

Yanqing Li0 sites120 target enrollmentMay 30, 2017

Overview

Phase
Phase 4
Intervention
amoxicillin
Conditions
Antimicrobial Susceptibility Testing
Sponsor
Yanqing Li
Enrollment
120
Primary Endpoint
Eradication rate of AST guided triple therapy
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 30, 2017
End Date
June 30, 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Yanqing Li
Responsible Party
Sponsor Investigator
Principal Investigator

Yanqing Li

Vice president of Qilu Hospital

Shandong University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Arms & Interventions

clarithromycin susceptible

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).

Intervention: amoxicillin

clarithromycin susceptible

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).

Intervention: clarithromycin

clarithromycin susceptible

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).

Intervention: Ilaprazole

metronidazole susceptible

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

Intervention: amoxicillin

metronidazole susceptible

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

Intervention: tinidazole

metronidazole susceptible

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

Intervention: Ilaprazole

levofloxacin susceptible

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

Intervention: amoxicillin

levofloxacin susceptible

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

Intervention: levofloxacin

levofloxacin susceptible

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

Intervention: Ilaprazole

furazolidone susceptible

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

Intervention: amoxicillin

furazolidone susceptible

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

Intervention: furazolidone

furazolidone susceptible

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

Intervention: Ilaprazole

tetracycline susceptible

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

Intervention: amoxicillin

tetracycline susceptible

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

Intervention: tetracycline

tetracycline susceptible

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

Intervention: Ilaprazole

Outcomes

Primary Outcomes

Eradication rate of AST guided triple therapy

Time Frame: 3 months

Secondary Outcomes

  • 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)

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