Comparison of Two Rescue Therapies for Helicobacter Pylori Infection

Study Overview
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Brief Summary
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From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.

Detailed Description
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The H pylori-infected adult patients with failure of standard triple therapy and H pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly assigned to either EALT (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.) therapy or EAL (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.) for 10 days. Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests is performed at six weeks after the end of anti-H pylori therapy.

Official Title
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Comparison of Two Rescue Therapies for Helicobacter Pylori Infection - A Multicenter Randomized Controlled Trial

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: esomeprazole+amox+levo+tetra
* Drug: esomeprazole+amox+levo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: positive results of both rapid urease test and histology, a positive result of urea breath test, or a positive result of culture. Exclusion Criteria: ingestion of antibiotics, bismuth, or proton pump inhibitor（PPI）within the prior 4 weeks, patients with allergic history to the medications used, patients with previous gastric surgery, the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia), pregnant women

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: esomeprazole+amox+levo+tetra<br>esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s. | Drug: esomeprazole+amox+levo+tetra<br>* esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.<br>* Other names: tetracycline 500 mg;|
| Active Comparator: esomeprazole+amox+levo<br>esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d. | Drug: esomeprazole+amox+levo<br>* esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.,<br>* Other names: levofloxacin 500 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants in Which H. Pylori Was Eradicated | Evaluate eradication outcome by endoscopy urease test and histology or urea breath test | six weeks after the end of anti-H pylori therapy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, Eradication rate, Rescue treatment