S0701, Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori (H. Pylori)

Study Overview
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Brief Summary
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The purpose of this study is to compare the effectiveness of three different antibiotic regimens against Helicobacter pylori (H. pylori).

Detailed Description
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Prevention of gastric cancer through eradication of H. pylori is one of the most promising strategies to reduce the global impact of cancer in the near term. Our long-term goal is to prevent gastric cancer by developing and validating an effective, simple, and low-cost approach to eradication of H. pylori. Our immediate goal, therefore, is to conduct a randomized study to compare the effectiveness of three different drug regimens for H. pylori infection. The three study arms are: Standard therapy - 14 day, 3-drug regimen of Lansoprazole, amoxicillin and clarithromycin (PACx14); Concomitant therapy - 5 day, 4-drug regimen of lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5); Sequential therapy - 10 day, 4-drug regimen of lansoprazole, amoxicillin for 5 days, followed by lansoprazole, clarithromycin and metronidazole for 5 days (PAx5/PCMx5).

Official Title
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A Phase III Randomized Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: PACx14
* Drug: PACMx5
* Drug: PAx5/PCMx5


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: positive Urea Breath Test documenting H. pylori infection age 21 - 65 years no known allergies to study drugs only member of household participating in study no known medical conditions (other than H. pylori) that would preclude or require antibiotic therapy patients must be willing to discontinue alcohol use for 15 days (maximum duration of treatment plus one day) patients must be willing to discontinue use of antacids for duration of study treatment patients must not have used proton pump inhibitors (PPI) within 30 days of registration. Patients also must be willing to stop using non-study provided PPIs until the completion of the 6 week follow-up contact. patients must not have been treated with antibiotics for H. pylori in the past and must not have taken any other antibiotics within 30 days of registration. patients must be willing to return for 2 follow-up visits: 6 weeks after randomization following completion of treatment & 1 year after randomization patients must be willing to allow submission of blood for assays of serum markers of bacterial virulence and host genetic susceptibility and environmental factors and provide consent for use of specimens. Exclusion Criteria: current use of anti-retroviral therapy for HIV or AIDS diagnosed congestive hear failure renal failure requiring dialysis diagnosed hepatic failure resulting in hyperbilirubinemia any current or prior malignancy except: adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or Stage II cancer from which the patient has been disease free for 5 years pregnancy or nursing mothers

Ages Eligible for Study
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Minimum Age: 21 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Standard 14 day, 3-drug regimen | Drug: PACx14<br>* Standard 14 day, 3 drug regimen: lansoprazole, amoxicillin, clarithromycin (PACx14)<br>* Other names: Lansoprazole: Prevacid;|
| Experimental: Arm 2<br>Concomitant Therapy - 5 day, 4-drug regimen | Drug: PACMx5<br>* Concomitant therapy - 5 day, 4 drug regimen: lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5)<br>* Other names: Lansoprazole: Prevacid;|
| Experimental: Arm 3<br>Sequential Therapy - 10 day, 4-drug regimen | Drug: PAx5/PCMx5<br>* Sequential Therapy - 10 day, 4-drug regimen: lansoprazole, amoxicillin for 5 days, followed by lansoprazole, clarithromycin and metronidazole for 5 days (PAx5/PCMx5)<br>* Other names: Lansoprazole: Prevacid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare 2 experimental antibiotic regimens with a standard 14 day regimen with regard to H. pylori eradication rates at 6 weeks post-randomization. |  | week 6 post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary aims will examine infection rates at 1 year, safety and tolerability of these regimens,& potential differential effects among selected groups. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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H. pylori