Antimicrobial Susceptibility Testing Guided Antibiotic Selection Strategies in Salvage Helicobacter Pylori Treatment
Phase 4
- Conditions
- Helicobacter Pylori InfectionAntimicrobial Susceptibility Testing
- Interventions
- Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin
- Registration Number
- NCT02988089
- Lead Sponsor
- Shandong University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 480
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description clarithromycin dependant group Clarithromycin susceptibility dependant strategy Patients in this group will receive 14-day bismuth-based quadruple therapies guided by the susceptibility of clarithromycin. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d. The kinds of 2 antibiotics will be depend on 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. clarithromycin dependant group amoxicillin and clarithromycin or amoxicillin and furazolidone Patients in this group will receive 14-day bismuth-based quadruple therapies guided by the susceptibility of clarithromycin. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d. The kinds of 2 antibiotics will be depend on 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. salvage therapy for failed eradication amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin If failed with AST guided eradication therapy, patients will take another therapy according to the former AST results. One susceptible antibiotics not involved in last therapy will be used as a component of 14-day bismuth-based quadruple regimen with Ilaprazole 5 mg b.i.d, amoxicillin 1 g b.i.d and Colloidal Bismuth Pectin 200 mg b.i.d. salvage therapy for negative culture amoxicillin and furazolidone or amoxicillin and tetracycline when the results of culture are negative, patients will receive Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, Colloidal Bismuth Pectin 200 mg (IAFB regimen) or Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, tetracycline 750 mg (IAFT regimen)，all are used twice daily except tetracycline which is taken 3 times daily. 6 antibiotics dependant group 2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline ) Patients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, a bismuth and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d. clarithromycin dependant group proton pump inhibitor (PPI) and Colloidal Bismuth Pectin Patients in this group will receive 14-day bismuth-based quadruple therapies guided by the susceptibility of clarithromycin. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d. The kinds of 2 antibiotics will be depend on 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. 6 antibiotics dependant group proton pump inhibitor (PPI) and Colloidal Bismuth Pectin Patients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, a bismuth and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d. salvage therapy for failed eradication proton pump inhibitor (PPI) and Colloidal Bismuth Pectin If failed with AST guided eradication therapy, patients will take another therapy according to the former AST results. One susceptible antibiotics not involved in last therapy will be used as a component of 14-day bismuth-based quadruple regimen with Ilaprazole 5 mg b.i.d, amoxicillin 1 g b.i.d and Colloidal Bismuth Pectin 200 mg b.i.d. salvage therapy for negative culture proton pump inhibitor (PPI) and Colloidal Bismuth Pectin when the results of culture are negative, patients will receive Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, Colloidal Bismuth Pectin 200 mg (IAFB regimen) or Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, tetracycline 750 mg (IAFT regimen)，all are used twice daily except tetracycline which is taken 3 times daily.
- Primary Outcome Measures
Name Time Method Eradication rates in 2 groups 6 months
- Secondary Outcome Measures
Name Time Method the rate of improving dyspepsia symptoms after H. pylori eradication 6 months the rate of adverse events happening 6 months the rate of good compliance (take pills more than 90%) 5 months difference of cost per patient for each eradication achieved in 2 groups 6 months
Trial Locations
- Locations (1)
Department of Gastroenterology, Qilu Hospital, Shandong University
🇨🇳Ji'nan, Shandong, China