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Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment

NCT03139253 — Phase 4, Unknown, 120 participants, Yanqing Li
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RegistryNCT03139253
StatusUnknown
PhasePhase 4
Study typeInterventional; non randomized, single group, masking: none, treatment
Enrollment120 (Estimated)
SponsorYanqing Li (Other)
ConditionsAntimicrobial Susceptibility Testing, Triple Therapy
Interventionsamoxicillin, clarithromycin, tinidazole, levofloxacin, furazolidone, tetracycline, Ilaprazole (Drug)
Datesstart 2017-05-30 (estimated), primary completion 2017-06-30 (estimated), completion 2017-06-30 (estimated), first posted 2017-05-03, last updated 2017-05-03

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
clarithromycin susceptibleExperimentalDrug: amoxicillin; Drug: clarithromycin; Drug: IlaprazolePatients 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).
metronidazole susceptibleExperimentalDrug: amoxicillin; Drug: tinidazole; Drug: IlaprazolePatients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tinidazole.
levofloxacin susceptibleExperimentalDrug: amoxicillin; Drug: levofloxacin; Drug: IlaprazolePatients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and levofloxacin.
furazolidone susceptibleExperimentalDrug: amoxicillin; Drug: furazolidone; Drug: IlaprazolePatients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and furazolidone.
tetracycline susceptibleExperimentalDrug: amoxicillin; Drug: tetracycline; Drug: IlaprazolePatients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tetracycline.
  • amoxicillin (Drug): amoxicillin 1000 mg bid. for 14 days
  • clarithromycin (Drug): clarithromycin 500 mg bid. for 14 days.
  • tinidazole (Drug): tinidazole 500 mg bid. for 14 days.
  • levofloxacin (Drug): levofloxacin 500 mg qd. for 14 days.
  • furazolidone (Drug): furazolidone 100 mg bid. for 14 days.
  • tetracycline (Drug): tetracycline 750 mg bid. for 14 days.
  • Ilaprazole (Drug): Ilaprazole 5 mg bid. for 14 days.

+Outcome measures

Primary outcomes

  • Eradication rate of AST guided triple therapy [3 months]

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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.

+Investigators

My Notes