Antimicrobial Susceptibility Testing Guided Antibiotic Selection Strategies in Salvage Helicobacter Pylori Treatment

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.

Conditions

• Helicobacter Pylori Infection
• Antimicrobial Susceptibility Testing

Interventions

DRUG

Clarithromycin susceptibility dependant strategy

Patients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. Antimicrobial susceptibility testing (AST) will be used to test the susceptibility of clarithromycin. If clarithromycin is susceptible, amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d will be chosen; If clarithromycin is resistant, amoxicillin 1 g bid and furazolidone 100 mg b.i.d will be chosen.

DRUG

2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline )

Patients in this group will receive a a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, Colloidal Bismuth Pectin and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.

DRUG

proton pump inhibitor (PPI) and Colloidal Bismuth Pectin

all patients need these two drugs.

DRUG

amoxicillin and clarithromycin or amoxicillin and furazolidone

patients in the 6 antibiotics dependant group will use these intervention.

DRUG

amoxicillin and furazolidone or amoxicillin and tetracycline

salvage therapy for negative culture when the results of culture are negative

DRUG

amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin

salvage therapy for failed eradication if failed with AST guided eradication therapy

Sponsors & Collaborators

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• General Hospital of Jinan Military Region

  collaborator UNKNOWN

• Binzhou People's Hospital

  collaborator OTHER

• Liaocheng People's Hospital

  collaborator OTHER

• Shandong University

  lead OTHER

Principal Investigators

• Li Yanqing, MD, PhD · Qilu Hospital of Shandong University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-20

Primary Completion

2017-09-30

Completion

2017-09-30

Countries

• China