Antimicrobial Susceptibility for Helicobacter Pylori Eradication
NCT ID: NCT01486082
Last Updated: 2011-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1 participants
OBSERVATIONAL
2011-02-28
2012-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Empirical OCA
This group will be treated with omeprazole, amoxicillin and clarithromycin without having a previous antibiogram.
OCA 10
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.
OCA after antibiogram
This group will be treated with omeprazole, clarithromycin and amoxicillin after an antibiotic susceptibility confirmation.
OCA 10
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.
Interventions
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OCA 10
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Patients who have severe concomitant disease.
* Patients who have previous gastric surgery.
* Patients who have intolerance to any antimicrobial drugs.
18 Years
80 Years
ALL
No
Sponsors
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Hospital Donostia
OTHER
Responsible Party
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LUIS BUJANDA
Director, Head of Gastroenterology Department, principal investigator, clinical proffesor
Principal Investigators
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LUIS BUJANDA
Role: STUDY_DIRECTOR
Locations
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Hospital Donostia
Donostia / San Sebastian, Guipuzcoa, Spain
Countries
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Central Contacts
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Facility Contacts
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LUIS BUJANDA, Dr
Role: primary
MAIDER MARTOS, Dr.
Role: backup
References
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Martos M, Bujanda L, Salicio Y, Sarasqueta C, Ibarra B, Mendarte U, Fernandez-Reyes M, Cosme A. Clarithromycin for first-line treatment of Helicobacter pylori infection after culture in high-resistance regions. Eur J Gastroenterol Hepatol. 2014 Dec;26(12):1380-4. doi: 10.1097/MEG.0000000000000197.
Other Identifiers
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HP02
Identifier Type: -
Identifier Source: org_study_id