Antimicrobial Susceptibility for Helicobacter Pylori Eradication

Study Overview
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Brief Summary
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Due to the high rate of resistance to clarithromycin in our area the investigators proposed an study to assess the need of antibiogram previous to the empirical OCA 10 treatment, in order to improve the rate of eradication.

Detailed Description
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Usefulness of antimicrobial susceptibility in the eradication of Helicobacter pylori PURPOSE Background: The rate of eradication of Helicobacter pylori with standard triple therapy (OCA: omeprazole + clarithromycin + amoxicillin) in our area is less than the expected according to the III Maastricht III consensus. However, the current guidelines recommend the use of this therapy. According to the Maastricht III consensus, in populations with high rates of clarithromycin resistance (15-20%) another therapy should be considered, or alternatively, testing antimicrobial susceptibility of the H. pylori prior to treatment. Objectives: To clarify the real rate of eradication with OCA therapy with and without antimicrobial susceptibility in our area (with high rate of resistance to clarythromycin). To study which is the diagnostic-therapeutic strategy more cost-effective for the treatment of H. pylori. Design: Participants will be screened with a full medical history. Participants will aleatory receive OCA therapy empirically, or after antimicrobial susceptibility test if there is no resistance to clarythromycin, for ten days. In all cases the eradication of H. pylori will be checked by 13C urea breath test (UBT) in 8 weeks after the therapy have been finished. All the adverse event of the therapy will be reported.

Official Title
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Usefulness of Antimicrobial Susceptibility in the Eradication of Helicobacter Pylori

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Other: OCA 10


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of H. pylori infection provided by culture, histology or UBT. Patients need and indication to treat (peptic ulcer disease, firs-degree family history of gastric cancer, MALT lymphoma or dyspeptic symptoms) Patients must be 18 years or older. Exclusion criteria: Previous treatment for H. pylori eradication. Patients who have severe concomitant disease. Patients who have previous gastric surgery. Patients who have intolerance to any antimicrobial 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Empirical OCA<br>This group will be treated with omeprazole, amoxicillin and clarithromycin without having a previous antibiogram. | Other: OCA 10<br>* A group will be treated with omeprazole (20 mg / 12 h), amoxicillin (1 g/ 12 h)and clarithromycin (500 mg/12 h) for 10 days (as following current guides) without having a previous antibiogram, and the other group will be treated after antibiotic susceptibility.<br>* Other names: A: Amoxicillin;|
| OCA after antibiogram<br>This group will be treated with omeprazole, clarithromycin and amoxicillin after an antibiotic susceptibility confirmation. | Other: OCA 10<br>* A group will be treated with omeprazole (20 mg / 12 h), amoxicillin (1 g/ 12 h)and clarithromycin (500 mg/12 h) for 10 days (as following current guides) without having a previous antibiogram, and the other group will be treated after antibiotic susceptibility.<br>* Other names: A: Amoxicillin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients in whom Helicobacter pylori was eradicated. | The investigators will measure the rate of eradication in each gruop after OCA treatment. One group receive OCA without antibiogram and the other one after checking the sensitivity to clarithromycin. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient with adverse event |  | 9 months | 
| Cost of the eradication of Helicobacter Pylori in each group. |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCA 10, Antibiogram, Eradication