Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori

Study Overview
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Brief Summary
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Comparison Efficacy of 14-day Concomitant therapy between levofloxacin and Clarithromycin on the Eradication of Helicobacter Pylori in Syrian population

Official Title
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Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori

Conditions
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Helicobacter Pylori Gastrointestinal Tract Infection

Intervention / Treatment
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* Drug: Clarithromycin 500Mg Oral Tablet
* 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: I-Positive rapid urease test (CLOtest). II-Histologic evidence of H. pylori by modified Giemsa staining. III-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, Tinidazole , Levofloxacin) and prompt pump inhibitors (Es-omeprazole). Contraindication to treatment drugs. Pregnant or lactating women. Severe concurrent disease. Liver cirrhosis. Chronic kidney disease. Patients who cannot give informed consent by himself or herself.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Clarithromycin :Concomitant Therapy<br>Amoxicillin 1000 mg Tablets, Clarithromycin 500 mg Tablets , Tinidazole 500 mg Tablets and Esomeprazole 20 mg Capsule each every 12 hours for 14 days all by mouth | Drug: Clarithromycin 500Mg Oral Tablet<br>* Amoxicillin 1000 mg Tablets every 12 hours , Esomeprazole 20 mg Capsule days all ,Clarithromycin 500 mg Tablets and Tinidazole 500 mg Tablets every 12 hours for 14 days all by mouth<br>* Other names: Tinidazole 500Mg Tablet;|
| Active Comparator: Levofloxacin :Concomitant Therapy<br>Levofloxacin 500 mg Tablets Amoxicillin 1000 mg Tablets,Tinidazole 500 mg Tablets and Esomeprazole 20 mg each every 12 hours for 14 days all by mouth | Drug: Levofloxacin 500Mg Oral Tablet<br>* Amoxicillin 1000 mg Tablets , Esomeprazole 20 mg Capsule,Levofloxacin 500 mg Tablets and Tinidazole 500 mg Tablets all every 12 hours for 14 days all by mouth<br>* Other names: Tinidazole 500Mg Tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori Eradication rate | Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis | 6 weeks after eradication therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, Helicobacter Infections, Proton Pump Inhibitors, sequential therapy, Clarithromycin, Tinidazole