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Status unknownNCT01486082Updated Dec 13, 2011

Antimicrobial Susceptibility for Helicobacter Pylori Eradication

An observational study in Helicobacter Pylori Infection, sponsored by Hospital Donostia. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-12-13.

Sponsored by Hospital Donostia · Observational

The sponsor has not verified this record recently (last verified Dec 2011), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Helicobacter Pylori Infection

Keywords

  • OCA 10
  • Antibiogram
  • Eradication
03

In context

Disease Susceptibility

141 studies on the registry are indexed under Disease Susceptibility; 31 are open to participants now.

This study's planned enrollment of 1 is below the median of 200 across 84 observational studies indexed under Disease Susceptibility.

Browse Disease Susceptibility studies →

Lead sponsor

Hospital Donostia is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1 participant (estimated)

Groups and cohorts

  • Empirical OCA

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

    Other: OCA 10

  • OCA after antibiogram

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

    Other: OCA 10

Interventions

  • OtherOCA 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.

    Also known as: O: Omeprazole, C: Clarithromycin, A: Amoxicillin

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 9 months

Secondary outcomes

  1. Number of patient with adverse event

    Time frame: 9 months

  2. Cost of the eradication of Helicobacter Pylori in each group.

    Time frame: 9 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 25229983 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01486082
Lead sponsor
Hospital Donostia
Responsible party
LUIS BUJANDA (Director, Head of Gastroenterology Department, principal investigator, clinical proffesor, Hospital Donostia) — Principal investigator
First posted
Dec 6, 2011
Start date
Feb 2011
Primary completion
Nov 2011
Completion
May 2012 (estimated)
Last update
Dec 13, 2011

Study contacts

LUIS BUJANDA, Dr.
Contact
luis.bujandafernandezdepierola@osakidetza.net
943 00 7173
LUIS BUJANDA
study director

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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