Antimicrobial Susceptibility for Helicobacter Pylori Eradication - Full Text View

Purpose

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.

Condition	Intervention	Phase
Helicobacter Pylori Infection	Other: OCA 10	Phase 4

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Usefulness of Antimicrobial Susceptibility in the Eradication of Helicobacter Pylori

Resource links provided by NLM:

Drug Information available for: Amoxicillin Amoxicillin sodium Omeprazole Clarithromycin Omeprazole magnesium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by Hospital Donostia:

Primary Outcome Measures:

Number of patients in whom Helicobacter pylori was eradicated. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
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:

Number of patient with adverse event [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Cost of the eradication of Helicobacter Pylori in each group. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1
Study Start Date:	February 2011
Estimated Study Completion Date:	May 2012
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Empirical OCA This group will be treated with omeprazole, amoxicillin and clarithromycin without having a previous antibiogram.	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. Other Names: O: Omeprazole C: Clarithromycin A: Amoxicillin
OCA after antibiogram This group will be treated with omeprazole, clarithromycin and amoxicillin after an antibiotic susceptibility confirmation.	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. Other Names: O: Omeprazole C: Clarithromycin A: Amoxicillin

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

The investigators recruited patients who are diagnosed with helicobacter pylori infection in our hospital (Hospital Donostia) or in any of the specialist care centres under the management of the Hospital Donostia.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01486082

Contacts

Contact: LUIS BUJANDA, Dr.

943 00 7173

luis.bujandafernandezdepierola@osakidetza.net

Locations

Spain
Hospital Donostia	Recruiting
San Sebastian, Guipuzcoa, Spain, 20014
Contact: LUIS BUJANDA, Dr 943 007173 luis.bujandafernandezdepierola@osakidetza.net
Contact: MAIDER MARTOS, Dr. 943 00 7173 maider.martosmartin@osakidetza.net
Principal Investigator: LUIS BUJANDA, Dr.

Sponsors and Collaborators

Hospital Donostia

Investigators

Study Director:

LUIS BUJANDA

More Information

No publications provided

Responsible Party:	LUIS BUJANDA, Director, Head of Gastroenterology Department, principal investigator, clinical proffesor, Hospital Donostia
ClinicalTrials.gov Identifier:	NCT01486082 History of Changes
Other Study ID Numbers:	HP02
Study First Received:	November 19, 2011
Last Updated:	December 11, 2011
Health Authority:	Spain: Ethics Committee

Keywords provided by Hospital Donostia:

OCA 10
Antibiogram
Eradication

Additional relevant MeSH terms:

Disease Susceptibility
Genetic Predisposition to Disease
Helicobacter Infections
Disease Attributes
Pathologic Processes
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Clarithromycin
Anti-Infective Agents

Omeprazole
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013