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Primary Antimicrobial Resistance Patterns of Austrian Helicobacter Pylori Clinical Isolates

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ClinicalTrials.gov Identifier: NCT02925091
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Christoph Steininger, Medical University of Vienna

Brief Summary:
Helicobacter pylori infects ~ 50% of the world's population and a quarter of the European population. H. pylori is responsible for a large proportion of gastric and duodenal ulcers and gastritis. Chronic infection with H. pylori is a risk factor for the development of stomach cancer and MALT (mucosa-associated lymphoid tissue) Lymphoma. The prospects of success for an antimicrobial eradication therapy is drastically reduced by the significant increase in antibiotic resistance in Austrian H. pylori isolates. The currently available data were obtained however from narrowly defined geographical regions and the clinical routine without information on patient selection. We suspect a considerable geographical variability of resistance patterns and a clinical bias for a preferential investigation of patients with unsuccessful, empirical eradication therapy. The objective of the proposed study is therefore an Austria-wide collection of data on H. pylori resistance in a prospective clinical study. The data thus collected will enable a significant improvement in current treatment recommendations.

Condition or disease
Helicobacter Pylori Infection

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Study Type : Observational
Actual Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : February 2015
Actual Primary Completion Date : July 2016



Primary Outcome Measures :
  1. Antimicrobial resistance of H. pylori isolate [ Time Frame: 1 day (Once) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Undergoing a diagnostic gastroscopy for the first time in their lives or had a diagnostic gastroscopy for any reason >10 years ago
Criteria

Inclusion Criteria:

  • Undergoing a diagnostic gastroscopy for the first time in their lives or had a diagnostic gastroscopy for any reason >10 years ago
  • Older than 18 years of age
  • Written informed consent

Exclusion Criteria:

  • Previous H. pylori eradication therapies
  • Antimicrobial treatment for other reasons than H. pylori eradication within 3 months prior to gastroscopy

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Christoph Steininger, Assoc. Prof., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02925091     History of Changes
Other Study ID Numbers: MUVienna_Helicobacter
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
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Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections