Eradication of H. Pylori Infection With Moxifloxacin

Study Overview
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Brief Summary
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The main objective of the study is to compare the effectiveness of moxifloxacin triple therapy with levofloxacin-based sequential therapy in terms of eradication rate, safety, and patient compliance.

Detailed Description
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Patients who were confirmed to be positive for Helicobacter Pylori infection were randomly assigned to the eradication treatments. At four weeks after completion of eradication therapy, H. pylori tests were performed with a Stool antigen test.

Official Title
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High Eradication Rate of Helicobacter Pylori Infection With Moxifloxacin-Based Triple Therapy in Comparison With Levofloxacin-Based Sequential Therapy: Randomized Controlled Trials

Conditions
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Helicobacter Pylori Infection, Helicobacter Pylori Infection, Susceptibility to

Intervention / Treatment
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* Drug: Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID
* Drug: Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Successful isolation of H. pylori from the patient, and patients of at least 18 years of age. Exclusion Criteria: age under 18 years presence of clinically signiﬁcant associated conditions (insulin-dependent diabetes mellitus, gastrointestinal bleeding, neoplastic diseases, coagulation disorders, and neurologic, metabolic, hematological or endocrine hepatic, cardiorespiratory, or renal diseases), previous gastric surgery, allergy to any of the drugs used in the study, and (5) pregnancy or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Interventional Model Description: Patients were randomized into two regimens: Levofloxacin 500mg BID, Amoxicillin 1 gm BID, Omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mg BID, Tinidazole 500mg BID, Omeprazole 20 mg BID, or Moxifloxacin 400 mg OD, Amoxicillin 1 gm BID, Omeprazole 20 mg BID.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levofloxacin-based sequential Therapy<br>Tablets Levofloxacin 500mg BID for the first five days Tablet Amoxicillin 1 gm BID for first five days Capsules Omeprazole 20 mg BID for first five days followed by 1. Tablet Levofloxacin 500 mg BID for five days 2. Tablet Tinidazole 500mg BID for five days 3. Capsule Omeprazole 20 mg BID for five days Infection eradication will be observed and confirmed by stool antigen test correlated with the signs and symptoms | Drug: Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID<br>* The eradication rate of H. Pylori with levofloxacin-based sequential therapy<br>* Other names: Tinidazole;|
| Active Comparator: Moxifloxacin-based Triple Therapy<br>Tablet Moxifloxacin 400 mg OD for ten days Tablet Amoxicillin 1 gm BID for ten days Capsule Omeprazole 20 mg BID for ten days Infection eradication will be observed and confirmed with a stool antigen test along with patient compliance and tolerability observance. | Drug: Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID<br>* The eradication rate of H. Pylori with moxifloxacin-based triple therapy<br>* Other names: Omeprazole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori status one month after treatment. | Helicobacter pylori status (positive or negative), will be measured by stool test, one month after finishing with therapy. | One month after finishing with therapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection. | Compliance will be measured by counting pills that were taken during therapy. More than or equal 80 % of taken pills will be consider as good compliance | One month after finishing with therapy. | 
| Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection. | Patients will be asked to report any adverse effect that occurred during treatment. They will be divided into groups according to the degree of limiting daily activities: no adverse effects; mild (no limit of activities); moderate (partially limited activities); severe (completely limited activities). | One month after finishing with therapy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Triple therapy with moxifloxacin, Helicobacter pylori, Levofloxacin sequential therapy, Stool Antigen test