5 Day Concomitant Versus 10 Day Sequential Therapy for Eradication of H. Pylori Infection

Study Overview
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Brief Summary
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A five day quadruple concomitant therapy is as effective and safe as a 10 day sequential therapy for eradication of H. pylori infection.

Detailed Description
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The investigators studied 180 consecutive patients with H. pylori infection who were randomized to 5-day concomitant therapy (90 patients) and to 10-day sequential therapy (90 patients). 6 and 10 weeks after the end of therapy, patients were evaluated for their H. pylori status by 13C Urea Breath Test. Side effects and costs of either regimen were evaluated. In patients whose H pylori status at entry was assessed by endoscopy, culture was performed and antimicrobial resistance was determined

Official Title
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Five-day Concomitant Versus 10-day Sequential Therapy for Eradication of Helicobacter Pylori Infection: a Randomized Trial of Levofloxacin-based Regimens

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: H. pylori-infected patients who were at least 18 years of age and who had never received H. pylori eradication treatment were included in the study. Exclusion Criteria: previous treatment for H. pylori infection, use of inhibitors of acid secretion and/or antibiotics during the 6 weeks before the study, gastrointestinal malignancy, previous gastro-oesophageal surgery, severe concomitant cardiovascular, respiratory or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders, any other clinically significant medical condition that could increase risk, history of allergy to any of the drug used in the study, pregnancy or lactation, alcohol abuse, drug addiction, severe neurologic or psychiatric disorders, and long-term use of corticosteroids or anti-inflammatory drugs.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5d-QCT<br>5-day eradication regimen consisting in the concomitant administration of esomeprazole 40mg bid + amoxicillin 1g bid + levofloxacin 500mg bid + tinidazole 500mg bid | Drug: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)<br>* amoxicillin tablets 1 g; esomeprazole tablets 40mg; tinidazole tablets 500mg; levofloxacin tablets 500 mg<br>* Other names: proton pump inhibitors;|
| Active Comparator: 10-day sequential regimen<br>5 days of esomeprazole 40mg bid + amoxicillin 40mg bid followed by 5 more days of esomeprazole 40mg bid + levofloxacin 500mg bid + tinidazole 500 mg bid | Drug: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)<br>* amoxicillin tablets 1 g; esomeprazole tablets 40mg; tinidazole tablets 500mg; levofloxacin tablets 500 mg<br>* Other names: proton pump inhibitors;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication Rate | The eradication rate obtained with the two treatments will be evaluated in the per-protocol and intention-to-treat analyses | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | The incidence of adverse events during therapy will be assessed: bad taste, taste alteration, nausea, vomiting, diarrhoea, epigastric pain, glossitis, headache | 1 year | 
| Costs of either regimen | The costs related to each treatment will be determined | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, Concomitant therapy, Sequential therapy, levofloxacin