Antimicrobial Susceptibility Testing Guided Triple Therapy 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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Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment

Conditions
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Antimicrobial Susceptibility Testing, Triple Therapy

Intervention / Treatment
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* Drug: amoxicillin
* Drug: clarithromycin
* Drug: tinidazole
* Drug: levofloxacin
* Drug: furazolidone
* Drug: tetracycline
* Drug: Ilaprazole


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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clarithromycin susceptible<br>Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and clarithromycin. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). | Drug: amoxicillin<br>* amoxicillin 1000 mg bid. for 14 days<br>Drug: clarithromycin<br>* clarithromycin 500 mg bid. for 14 days.<br>Drug: Ilaprazole<br>* Ilaprazole 5 mg bid. for 14 days.<br>|
| Experimental: metronidazole susceptible<br>Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tinidazole. | Drug: amoxicillin<br>* amoxicillin 1000 mg bid. for 14 days<br>Drug: tinidazole<br>* tinidazole 500 mg bid. for 14 days.<br>Drug: Ilaprazole<br>* Ilaprazole 5 mg bid. for 14 days.<br>|
| Experimental: levofloxacin susceptible<br>Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and levofloxacin. | Drug: amoxicillin<br>* amoxicillin 1000 mg bid. for 14 days<br>Drug: levofloxacin<br>* levofloxacin 500 mg qd. for 14 days.<br>Drug: Ilaprazole<br>* Ilaprazole 5 mg bid. for 14 days.<br>|
| Experimental: furazolidone susceptible<br>Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and furazolidone. | Drug: amoxicillin<br>* amoxicillin 1000 mg bid. for 14 days<br>Drug: furazolidone<br>* furazolidone 100 mg bid. for 14 days.<br>Drug: Ilaprazole<br>* Ilaprazole 5 mg bid. for 14 days.<br>|
| Experimental: tetracycline susceptible<br>Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tetracycline. | Drug: amoxicillin<br>* amoxicillin 1000 mg bid. for 14 days<br>Drug: tetracycline<br>* tetracycline 750 mg bid. for 14 days.<br>Drug: Ilaprazole<br>* Ilaprazole 5 mg bid. for 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate of AST guided triple therapy |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of improving dyspepsia symptoms after H. pylori eradication |  | 3 months | 
| the rate of adverse events happening |  | 3 months | 
| the rate of good compliance (take pills more than 90%) |  | 3 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), Triple Therapy