Antimicrobial Susceptibility for Helicobacter Pylori Eradication

• Conditions: Helicobacter Pylori Infection
• Interventions: Other: OCA 10

• Registration Number: NCT01486082
• Lead Sponsor: Hospital Donostia

Brief 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.

Detailed 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 Timeline

• Study Start: 2011-02
• Primary Completion: 2011-11
• Study First Submitted: 2011-11-19
• Status Verified: 2011-12
• Study First Submitted QC: 2011-12-02
• Study First Posted: 2011-12-06
• Last Update Submitted: 2011-12-11
• Last Update Posted: 2011-12-13
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Empirical OCA	OCA 10	This group will be treated with omeprazole, amoxicillin and clarithromycin without having a previous antibiogram.
OCA after antibiogram	OCA 10	This group will be treated with omeprazole, clarithromycin and amoxicillin after an antibiotic susceptibility confirmation.

Primary Outcome Measures

Name	Time	Method
Number of patients in whom Helicobacter pylori was eradicated.	9 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of patient with adverse event	9 months
Cost of the eradication of Helicobacter Pylori in each group.	9 months

Trial Locations

Locations (1)

Hospital Donostia; 🇪🇸 San Sebastian, Guipuzcoa, Spain