Efficacy and Safety Evaluation of Levofloxacin Triple Therapy for Helicobacter Pylori Eradication

Study Overview
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Brief Summary
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Today, although the triple treatment with clarithromycin accepted as the primary treatment for Helicobacter pylori infection eradication is well tolerated, the eradication has been decreased to 65 %. However, the eradication resulting from TRIOL treatment with levofloxacin is expected to be 75 % or higher. If the target results can be reached, it will be concluded that TRIOL treatment with levofloxacin will be an alternative to the triple treatment with clarithromycin as the primary treatment.

Detailed Description
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The primary end point in this study is appointed to be Helicobacter pylori infection eradication with TRIOL treatment and the secondary end point as safety. The study involves the investigation of the efficacy and safety of the triple treatment consisting of 500 mg levofloxacin, 1000 mg amoxicillin and 30 mg lansoprazole on Helicobacter pylori eradication in 60 patients with Helicobacter pylori infection.

Official Title
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A Monocentric, Open-label, Efficacy and Safety Evaluation Study of the Triple Therapy of 500 mg Levofloxacin, 1000 mg Amoxicillin and 30 mg Lansoprazole on Helicobacter Pylori Eradication in 60 Patients Infected With H. Pylori

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Levofloxacin
* Drug: Amoxicillin
* Drug: Lansoprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consenting to an endoscopy Signing the informed consent form Not receiving Helicobacter pylori eradication treatment before Showing Helicobacter pylori infection by rapid urease test and/or Giemsa staining Being older than 18 years of age Exclusion Criteria: Being younger than 18 years of age Receiving H. pylori eradication treatment previously Having gastrectomy or vagotomy in medical history Having gastric malignancy, including adenocarcinoma and lymphoma Having other severe malignant disease Previously having allergic reaction to antibiotics (amoxicillin, levofloxacin) and proton pump inhibitors (lansoprazole) Using prompt pump inhibitors (lansoprazole) and antibiotics (amoxicillin, clarithromycin, levofloxacin) in the last 4 weeks Having active upper GI bleeding in the last week Being pregnant or lactating Taking long term high dosages of aspirin, corticosteroid and other NSAIDs in the last 4 weeks Taking any antibiotics or proton pump inhibitors other than the study medication during the study period Taking antacids and/or H2-blockers during the study period Taking bismuth compounds within four weeks prior to and during the study period Having dysphasia or vomiting as major symptoms Having psychiatric, neurological, or behavioral disorders that may interfere with the conduct or interpretation of the study Having severe concomitant disease of the cardiovascular, pulmonic, hepatic, renal, hematological, lymphatic, metabolic, and endocrine system. Having known uncontrolled hypertension Being immunocompromised Showing clinically significant abnormal vital signs Having clinically significant abnormal ECG findings Presenting clinically significant abnormal laboratory data at screening, or any abnormal laboratory value that could interfere with the assessment of safety Being exposed to any investigational drug within 30 days prior to screening Having known hypersensitivity to or contraindication against fluoroquinolones. Having current diagnosis or known history of substance abuse.

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levofloxacin|tablet, 500 mg, once a day for ten days|
|Drug: Amoxicillin|tablet, 1000 mg, once a day for ten days|
|Drug: Lansoprazole|capsule, 30 mg, twice a day for ten days|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori infection eradication | After 6 weeks from the end of the TRIOL treatment, demonstrating the ratio of patients who do not develop Helicobacter pylori infection by rapid urease test and Giemsa staining. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | During the study all patients will be examined at the determined timepoints in the protocol in regard to any type of clinical adverse event. These examinations involve clinical and laboratory examinations of which the results will be recorded in the final study report and discussed with respect to the current literature. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, levofloxacin, amoxicillin, lansoprazole, efficacy, safety, triple therapy