Susceptibility Testing Guided Versus Empirical Therapy for Refractory H. Pylori Infection

Study Overview
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Brief Summary
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Aim: Therefore, we aimed to compare the efficacy of susceptibility testing guided therapy vs. empirical therapy in the third-line eradication for refractory H. pylori infection assess the long-term impact of eradication therapy on the antibiotic resistance and microbiota of the gut flora and the metabolic factors. Methods: This will be a multi-center, open labeled trial Patients: 360 patients with failure to H. pylori eradication for at least two times will be enrolled Determination of antibiotic resistance of H. pylori: Agar dilution test will be used to determine the minimum inhibitory concentrations of levofloxacin, tetracycline, rifabutin, and clarithromycin to guide the selection of antibiotics. Treatment regimens and assignment: Eligible patients will be randomized to receive either one of the treatments (A) Susceptibility testing guided therapy or (B) Empirical therapy Outcome Measurement: Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) analyses. Secondary End Point: 1. Eradication rate according to per protocol analysis (PP analysis); 2. Frequency of adverse effects.

Official Title
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Comparison of Susceptibility Testing Guided Versus Empirical Therapy for the Third-line Eradication of H. Pylori- a Multicenter Randomized Trial

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: ET
* Drug: SGT


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Adult (equal or greater than 20 years old) patients who failed from at least two eradication therapies for H. pylori infection will be enrolled.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 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: (B) Empirical therapy<br>choose antibiotics according to drug history | Drug: ET<br>* Empirical therapy Based on drug history: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin triple therapy or concomitant therapy<br>|
| Active Comparator: (A) Susceptibility testing guided therapy<br>choose antibiotics according to susceptibility testing | Drug: SGT<br>* Susceptibility testing guided therapy Based on susceptibility test: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin triple therapy or concomitant therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is the eradication rate in the third treatment according to intention-to treat (ITT) analysis. | Eradication rate will be determined by urea breath test at least 6 weeks after completion of treatment. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects | A standard interview and questionaire will be used to assess the adverse effects. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori,Susceptibility testing,empirical,third-line treatment