Levofloxacin Triple and Bismuth Quadruple Therapies for Rescue Treatment of H 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 EAL (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.) or EBTL (esomeprazole 40 mg b.d., bismuth 500 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.) therapy 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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A Prospective Randomized Trial of Levofloxacin-amoxicillin Triple Therapy vs. Levofloxacin-tetracycline Quadruple Therapy in Second-line Helicobacter Pylori Treatment

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: esomeprazole+amox+levo
* Drug: esomeprazole+bismuth+tetra+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 |
| --- | --- |
| 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;|
| Experimental: esomeprazole+bismuth+tetra+levo<br>esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d. | Drug: esomeprazole+bismuth+tetra+levo<br>* esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and 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 | Number of participants with negative H pylori status in follow-up tests as a measure of successful eradication | 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