Antimicrobial Susceptibility for Helicobacter Pylori Eradication

Hospital Donostia

Status: Unknown

Conditions: Helicobacter Pylori Infection

Treatments: Other: OCA 10

Study type: Observational

Funder types: Other

Identifiers

NCT01486082

HP02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 estimated patient

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1 participants in 2 patient groups

Empirical OCA

Description:

This group will be treated with omeprazole, amoxicillin and clarithromycin without having a previous antibiogram.

Treatment:

Other: OCA 10

OCA after antibiogram

Description:

This group will be treated with omeprazole, clarithromycin and amoxicillin after an antibiotic susceptibility confirmation.

Treatment:

Other: OCA 10