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NCT02925091 Clinical Trial

Primary Antimicrobial Resistance Patterns of Austrian Helicobacter Pylori Clinical Isolates

Helicobacter Pylori Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02925091
Other study ID # MUVienna_Helicobacter
Secondary ID
Status Completed
Phase N/A
First received October 4, 2016
Last updated October 4, 2016
Start date February 2015

Study information
Verified date October 2016
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 2000
Est. completion date
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Outcome
Type Measure Description Time frame Safety issue
Primary Antimicrobial resistance of H. pylori isolate 1 day (Once) No
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