Genotypic Resistance Guided Therapy in Helicobacter Pylori Eradication

Study Overview
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Brief Summary
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We aimed to compare the efficacy of genotypic resistance guided sequential therapy vs. empiric therapy in the third line therapy. Factors affecting the eradication rates, including the antibiotic resistance, CYP2C19 polymorphism, CagA and VacA status will also be assessed.

Detailed Description
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The primary aim of this study is to compare the regimens selected using either one of the method (1) genotypic resistance guided versus (2) medication history guided therapy. (rather than to compare the efficacy of any drugs).

Official Title
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Genotypic Resistance Guided Therapy in the Treatment of Helicobacter Pylori Infection

Conditions
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Self Efficacy

Intervention / Treatment
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* Drug: empirical therapy
* Drug: Genotypic resistance guided therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged greater than 20 years who have persistent H. pylori infection after at least two treatments and are willing to receive third line rescue regimens are considered eligible for enrollment. Exclusion Criteria: Patients will be excluded from the study if any one of the following criteria is present: (1) children and teenagers aged less than 20 years, (2) history of gastrectomy, (3)gastric malignancy, including adenocarcinoma and lymphoma, (4) previous allergic reaction to antibiotics (Amoxicillin, Klaricid, Cravit) and prompt pump inhibitors (esomeprazole), (5)contraindication to treatment drugs, (6) pregnant or lactating women, (7) severe concurrent disease.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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 |
| --- | --- |
| Active Comparator: Empirical therapy<br>selection of antibiotic according to medication history | Drug: empirical therapy<br>* Nexium (esomeprazole), 40mg, bid, 14 days, plus Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs Select either one of the drugs according to medication history Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14<br>* Other names: selection of antibiotics according to medication history;|
| Experimental: Genotypic resistance guided therapy<br>selection of antibiotics according to genotypic resistance | Drug: Genotypic resistance guided therapy<br>* Nexium (esomeprazole), 40mg, bid, 14 days, plus Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs Select either one of the drugs according to genotypic resistance results Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14<br>* Other names: selection of antibiotic according to genotypic resistance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate after third line rescue therapy | Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) and per-protocol (PP) analyses. (genotypic resistance versus empirical therapy) Urea breath test will be used to determine the eradication status | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eradication rates in subgroup analysis by antibiotic resistance and regimen | eradication rate in subgroup analysis according to antibiotic resistance and treatment regimen | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genotypic resistance guided therapy