Levofloxacin-containing Therapies In Second Line Helicobacter Pylori Eradication

Study Overview
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Brief Summary
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Asia Pacific Consensus states that levofloxacin-based triple therapy as an alternative second-line therapy after Helicobacter pylori (H. pylori) eradication failure when bismuth salts are not available. The investigators compare the efficacies of 10-day levofloxacin-based sequential therapy and 10-day triple therapy in the treatment for patients after failure of standard triple therapy and to determine what clinical and bacterial factors influencing the efficacy of salvage regimens.

Detailed Description
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In this randomized-controlled trial , the investigator recruited participants with H pylori infection after failure of first line standard triple therapy. Using a computer-generated randomization sequence, the investigators randomly allocated patients to either 10-day levofloxacin-containing sequential (EALM, esomeprazole 40 mg b.d., amoxicillin 1 g b.d.for 5 days and followed by esomeprazole 40 mg b.d., levofloxacin 500 mg qd and metronidazole for 5 days) or 10-day levofloxacin-containing triple therapy (EAL, esomeprazole 40 mg b.d., amoxicillin 1 g b.d., and levofloxacin 500 mg qd) at a 1:1 ratio. The primary outcome was the eradication rate by intention-to-treat and per-protocol analyses.

Official Title
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The Efficacy of 10-day Metronidazole and Levofloxacin Containing Sequential Therapy and 10-day Levofloxacin-containing Triple Therapy In Second Line Helicobacter Pylori Eradication Therapies

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Nexium
* Drug: Amolin
* Drug: Cravit
* Drug: Flagyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive H. pylori-infected participants, at least 18 years of age, with endoscopically proven peptic ulcer diseases or gastritis who failed first-line eradication therapies with standard triple regimens (PPI twice daily, 500 mg of clarithromycin twice daily and 1 g of amoxicillin twice daily) Exclusion Criteria: Ingestion of antibiotics, bismuth, or proton-pump inhibitors within the prior 4 weeks Use of non-steroidal anti-inflammatory drugs within the prior 4 weeks Participants with allergic history to the medications used Participants 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: 18 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequential therapy<br>Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days | Drug: Nexium<br>* Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms<br>* Other names: Esomeprazole;Drug: Amolin<br>* Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm<br>* Other names: Amoxicillin;Drug: Cravit<br>* Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm<br>* Other names: Levofloxacin;Drug: Flagyl<br>* Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm<br>* Other names: Metronidazole;|
| Active Comparator: Triple therapy<br>Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days | Drug: Nexium<br>* Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms<br>* Other names: Esomeprazole;Drug: Amolin<br>* Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm<br>* Other names: Amoxicillin;Drug: Cravit<br>* Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm<br>* Other names: Levofloxacin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Successful Eradication of H. Pylori | Successful eradication of H. pylori is defined as (1) negative results of both rapid urease test and histology, or (2) a negative result of urea breath test at 4 weeks. | Negative results of H.pylori 4 weeks after eradication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, Proton pump inhibitor, Eradication