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

Shandong University480 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

480

Conditions

Helicobacter Pylori Infection Antimicrobial Susceptibility Testing

Interventions

Clarithromycin susceptibility dependant strategyDRUG

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.

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

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Ji'nan, Shandong, China

RECRUITING

Outcomes

Primary Outcomes

Eradication rates in 2 groups

Time frame: 6 months

Secondary Outcomes

the rate of improving dyspepsia symptoms after H. pylori eradication

Time frame: 6 months

the rate of adverse events happening

Time frame: 6 months

the rate of good compliance (take pills more than 90%)

Time frame: 5 months

difference of cost per patient for each eradication achieved in 2 groups

Time frame: 6 months

Central Contacts

Li Yanqing, MD, PhD

CONTACT

86-531-82169236 liyanqing@sdu.edu.cn

Data from ClinicalTrials.gov

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