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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01486082
Study type Observational
Source Hospital Donostia
Contact LUIS BUJANDA, Dr.
Phone 943 00 7173
Email luis.bujandafernandezdepierola@osakidetza.net
Status Recruiting
Phase Phase 4
Start date February 2011
Completion date May 2012

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