Antimicrobial Susceptibility for Helicobacter Pylori Eradication

Helicobacter Pylori Infection Clinical Trial

Official title:

Usefulness of Antimicrobial Susceptibility in the Eradication of Helicobacter Pylori

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01486082
• Other study ID #: HP02
• Status: Recruiting
• Phase: Phase 4
• First received: November 19, 2011
• Last updated: December 11, 2011
• Start date: February 2011
• Est. completion date: May 2012

Study information

• Verified date: December 2011
• Source: Hospital Donostia
• Contact: LUIS BUJANDA, Dr.
• Phone: 943 00 7173
• Email: luis.bujandafernandezdepierola[@]osakidetza.net
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: May 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disease Susceptibility
• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Donostia	San Sebastian	Guipuzcoa

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Donostia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients in whom Helicobacter pylori was eradicated.	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.	9 months	Yes
Secondary	Number of patient with adverse event		9 months	Yes
Secondary	Cost of the eradication of Helicobacter Pylori in each group.		9 months	Yes