NCT01486082

Antimicrobial Susceptibility for Helicobacter Pylori Eradication

Usefulness of Antimicrobial Susceptibility in the Eradication of Helicobacter Pylori

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1 (estimated)
• Sponsor: Hospital Donostia · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-11-01
• Completion: 2012-05-01
• First posted: 2011-12-06
• Last updated: 2011-12-13

Locations

1 site across 1 country: Spain