Levofloxacin Concomitant Versus Levofloxacin Sequential

Study Overview
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Brief Summary
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The goal of this trial is to determine the efficacy of levofloxacin based sequential treatment regimen or concomitant levofloxacin based regimens as empirical first-line therapy in the Syrian population

Official Title
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Efficacy of Two-week Therapy With Levofloxacin-based Concomitant Regimen Versus Levofloxacin-based Sequential Regimen for Helicobacter Pylori Infection in Syrian Population: a Prospective Single-center Randomized Controlled Trial

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: sequential
* Drug: Levofloxacin 500Mg Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods: Positive rapid urease test (CLOtest). Histologic evidence of H. pylori by modified Giemsa staining. Positive 13C-urea breath test. without prior eradication therapy and are willing to receive therapy. Exclusion Criteria: Children and teenagers aged less than 18 years. Previous eradication treatment for H. pylori. Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics. History of gastrectomy. Gastric malignancy, including adenocarcinoma and lymphoma, Previous allergic reaction to antibiotics (Amoxicillin, Tinadizole, Doxycycline,Bismuth subsalicylate,) and prompt pump inhibitors (Es- omeprazole). Contraindication to treatment drugs. Pregnant or lactating women. Severe concurrent disease. Liver cirrhosis.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sequential<br>Measure eradication rate of Helicobacter pylori infection with Levofloxacien sequential based regimen | Drug: sequential<br>* amoxicillin 1000 mg bid ,esomprazole 20 bid for one week then levofloxacine 500 mg q.d, metraonidazoel 500 500 bid, and esomprazole 20 bid for one week<br>* Other names: amoxicillin;|
| Active Comparator: concomitant<br>Measure eradication rate of Helicobacter pylori infection with Livofloxacine concomitant based regimen | Drug: Levofloxacin 500Mg Oral Tablet<br>* Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid<br>* Other names: Tinadizole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate of Helicobacter pylori infection | Eradication rate of Helicobacter infected patients | 8 week from begning of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter Pylori, levofloxacine, concomitant, sequential