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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Two Antimicrobial Susceptibility Testing Guided Antibiotic Selection Strategies in Salvage Helicobacter Pylori Treatment

Conditions
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Helicobacter Pylori Infection, Antimicrobial Susceptibility Testing

Intervention / Treatment
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* Drug: Clarithromycin susceptibility dependant strategy
* Drug: 2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline )
* Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin
* Drug: amoxicillin and clarithromycin or amoxicillin and furazolidone
* Drug: amoxicillin and furazolidone or amoxicillin and tetracycline
* Drug: amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clarithromycin dependant group<br>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. | Drug: Clarithromycin susceptibility dependant strategy<br>* 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.<br>Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin<br>* all patients need these two drugs.<br>Drug: amoxicillin and clarithromycin or amoxicillin and furazolidone<br>* patients in the 6 antibiotics dependant group will use these intervention.<br>|
| Experimental: 6 antibiotics dependant group<br>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. | Drug: 2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline )<br>* 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.<br>Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin<br>* all patients need these two drugs.<br>|
| Other: salvage therapy for negative culture<br>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. | Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin<br>* all patients need these two drugs.<br>Drug: amoxicillin and furazolidone or amoxicillin and tetracycline<br>* salvage therapy for negative culture when the results of culture are negative<br>|
| Other: salvage therapy for failed eradication<br>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. | Drug: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin<br>* all patients need these two drugs.<br>Drug: amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin<br>* salvage therapy for failed eradication if failed with AST guided eradication therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rates in 2 groups |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter Pylori Infection, Antimicrobial susceptibility testing (AST)