Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Triple Therapy as Second Line Therapy

Study Overview
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Brief Summary
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To compare the efficacy and tolerability of levofloxacin-based sequential therapy and triple therapy in the second line therapy for those who fail from one eradication therapy

Detailed Description
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About 600 patients who failed from first line triple therapy or sequential therapy will be eligible in this multicenter randomized comparative trial. Eligible patients will be randomized to receive either (1) levofloxacin-based sequential therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g for the first 5 days, followed by lansoprazole 30mg, levofloxacin 250mg, and metronidazole 500mg for another 5 days (all given twice daily)〕or (2) levofloxacin-based triple therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)〕. Eradication will be confirmed with 13C-Urea Breath Test 6 weeks after therapy.

Official Title
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Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Triple Therapy as Second Line Therapy for Refractory Helicobacter Pylori Infection- A Multi-center Randomized Trial

Conditions
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Eradication Rate for Helicobacter

Intervention / Treatment
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* Drug: levofloxacin-based sequential therapy
* Drug: levofloxacin-based triple therapy for 10 days


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: H. pylori infected patients who failed from first line therapy will be eligible in this study Exclusion Criteria: Patients were excluded from the study if any one of the following criteria was present: children and teenagers aged less than 20 years, history of gastrectomy, gastric malignancy, including adenocarcinoma and lymphoma, previous allergic reaction to antibiotics (amoxicillin, metronidazole, levofloxacin) and PPI (lansoprazole), contraindication to treatment drugs, pregnant or lactating women, or severe concurrent disease

Ages Eligible for Study
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Minimum Age: 20 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: levofloxacin-based sequential therapy<br>levofloxacin-based sequential therapy | Drug: levofloxacin-based sequential therapy<br>* levofloxacin-based sequential therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g for the first 5 days, followed by lansoprazole 30mg, levofloxacin 250mg, and metronidazole 500mg for another 5 days (all given twice daily)〕<br>* Other names: Amoxicillin;|
| Active Comparator: levofloxacin-based triple therapy<br>levofloxacin-based triple therapy for 10 days | Drug: levofloxacin-based triple therapy for 10 days<br>* lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)<br>* Other names: Amoxicillin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate in the second line therapy | Assessed by UBT | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse effect | during treatment | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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H pylori eradication