Efficacies of Antimicrobial Susceptibility-Guided Versus Empirical Therapy for Rescue Treatment of Helicobacter Pylori Infection-A Randomized Clinical Trial
Overview
- Phase
- Phase 4
- Intervention
- two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline)
- Conditions
- Helicobacter Pylori Infection
- Sponsor
- Shandong University
- Enrollment
- 420
- Locations
- 1
- Primary Endpoint
- Eradication rates
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to assess efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection, then comparing it with 14-day empirical therapy according to personal medication history.
Detailed Description
Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been classified as the first risk factor of gastric cancer. Strong evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathological processes. Antimicrobial susceptibility test can pick out sensitive drugs to kill H.pylori, and reduce secondary drug resistance. However, there is a lack of high quality RCT to evaluate its efficacy in the rescue treatment of Helicobacter infection. The investigator's study aims to assess the efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection. Then, comparing this regimen with 14-day empirical therapy according to personal medication history to tell which one is better in clinic practice.
Investigators
Xiuli Zuo
director of Qilu Hospital gastroenterology department
Shandong University
Eligibility Criteria
Inclusion Criteria
- •Patients aged 18-70 with persistent Helicobacter pylori infection.
- •Patients with previous Helicobacter pylori eradication therapy for one or two times.
Exclusion Criteria
- •Patients unable or unwilling to receive gastroscopy.
- •Patients treated with Histamine-receptor antagonist, proton pump inhibitor, bismuth and antibiotics in the previous 4 weeks.
- •Patients with gastrectomy, acute gastrointestinal bleeding and advanced gastric cancer.
- •Patients with known or suspected allergy to study medications.
- •Currently pregnant or lactating.
- •Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Arms & Interventions
Antimicrobial susceptibility guided therapy
Patients in this group will receive a 14-day quadruple therapy for helicobacter pylori eradication. The regimen contains one proton pump inhibitor, colloidal bismuth pectin, and two sensitive antibiotics determined by antimicrobial susceptibility test. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated. Drugs: 1.one proton pump inhibitor: rabeprazole 10mg bid for 14d, 2.Colloidal Bismuth Pectin 200mg bid for 14d, 3.two sensitive antibiotics: amoxicillin 1000mg bid for 14d, clarithromycin 500mg bid for 14d, metronidazole 500mg tid for 14d, tinidazole 500mg tid for 14d, levofloxacin 500mg qd for 14d, furazolidone 100mg bid for 14d, tetracycline 500mg qid for 14d.
Intervention: two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline)
Antimicrobial susceptibility guided therapy
Patients in this group will receive a 14-day quadruple therapy for helicobacter pylori eradication. The regimen contains one proton pump inhibitor, colloidal bismuth pectin, and two sensitive antibiotics determined by antimicrobial susceptibility test. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated. Drugs: 1.one proton pump inhibitor: rabeprazole 10mg bid for 14d, 2.Colloidal Bismuth Pectin 200mg bid for 14d, 3.two sensitive antibiotics: amoxicillin 1000mg bid for 14d, clarithromycin 500mg bid for 14d, metronidazole 500mg tid for 14d, tinidazole 500mg tid for 14d, levofloxacin 500mg qd for 14d, furazolidone 100mg bid for 14d, tetracycline 500mg qid for 14d.
Intervention: one proton pump inhibitor, colloidal bismuth pectin
Empirical therapy according to medication history
Patients in this group will receive a 14-day quadruple therapy based on personal medication history for helicobacter pylori eradication. The regimen contains one proton pump inhibitor, Colloidal Bismuth Pectin and two antibiotics chosen according to medication history. If the patient hasn't been treated with levofloxacin in the previous eradication regimen, he will be treated with amoxicillin and levofloxacin. Otherwise, he will be treated with amoxicillin and furazolidone. Drugs: 1.one proton pump inhibitor: rabeprazole 10mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics based on personal medication history: amoxicillin 1000mg bid and levofloxacin 500mg qd for 14d, amoxicillin 1000mg bid and furazolidone 100mg bid for 14d.
Intervention: one proton pump inhibitor, colloidal bismuth pectin
Empirical therapy according to medication history
Patients in this group will receive a 14-day quadruple therapy based on personal medication history for helicobacter pylori eradication. The regimen contains one proton pump inhibitor, Colloidal Bismuth Pectin and two antibiotics chosen according to medication history. If the patient hasn't been treated with levofloxacin in the previous eradication regimen, he will be treated with amoxicillin and levofloxacin. Otherwise, he will be treated with amoxicillin and furazolidone. Drugs: 1.one proton pump inhibitor: rabeprazole 10mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics based on personal medication history: amoxicillin 1000mg bid and levofloxacin 500mg qd for 14d, amoxicillin 1000mg bid and furazolidone 100mg bid for 14d.
Intervention: two antibiotics based on personal medication history(amoxicillin,levofloxacin, furazolidone)
Outcomes
Primary Outcomes
Eradication rates
Time Frame: 6 months
Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infection. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Secondary Outcomes
- The rates of adverse events happening(6 months)
- The rates of improving dyspepsia symptoms after helicobacter pylori eradication.(6 months)
- The rates of good compliance.(6 months)