Clinical trial NCT01486082: Antimicrobial Susceptibility for Helicobacter Pylori Eradication
Official title: Usefulness of Antimicrobial Susceptibility in the Eradication of Helicobacter Pylori
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Helicobacter Pylori Infection
Keywords: OCA 10
Antibiogram
Eradication
Lead sponsor: Hospital Donostia
Sponsor class: OTHER
First posted: 2011-12-06
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of patients in whom Helicobacter pylori was eradicated.
timeFrame: 9 months
Secondary outcomes:
measure: Number of patient with adverse event
timeFrame: 9 months
measure: Cost of the eradication of Helicobacter Pylori in each group.
timeFrame: 9 months
Other outcomes:
Locations:
city: San Sebastian
country: Spain
facility: Hospital Donostia
state: Guipuzcoa
Study officials:
name: LUIS BUJANDA
role: STUDY_DIRECTOR
References:
citation: Martos M, Bujanda L, Salicio Y, Sarasqueta C, Ibarra B, Mendarte U, Fernandez-Reyes M, Cosme A. Clarithromycin for first-line treatment of Helicobacter pylori infection after culture in high-resistance regions. Eur J Gastroenterol Hepatol. 2014 Dec;26(12):1380-4. doi: 10.1097/MEG.0000000000000197.