Primary Antimicrobial Resistance Patterns of Austrian Helicobacter Pylori Clinical Isolates

NCT02925091 | Completed

• 1 other identifier: MUVienna_Helicobacter
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Antimicrobial resistance of H. pylori isolate

  1 day (Once)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Related Publications (1)

• Bilgilier C, Stadlmann A, Makristathis A, Thannesberger J, Kastner MT, Knoflach P, Steiner P, Schoniger-Hekele M, Hogenauer C, Blesl A, Datz C, Huber-Schonauer U, Schofl R, Wewalka F, Puspok A, Mitrovits N, Leiner J, Tilg H, Effenberger M, Moser M, Siebert F, Hinterberger I, Wurzer H, Stupnicki T, Watzinger N, Gombotz G, Hubmann R, Klimpel S, Biowski-Frotz S, Schrutka-Kolbl C, Graziadei I, Ludwiczek O, Kundi M, Hirschl AM, Steininger C; Austrian Helicobacter Study Group of the Austrian Society of Gastroenterology and Hepatology. Prospective multicentre clinical study on inter- and intrapatient genetic variability for antimicrobial resistance of Helicobacter pylori. Clin Microbiol Infect. 2018 Mar;24(3):267-272. doi: 10.1016/j.cmi.2017.06.025. Epub 2017 Jun 29.

  PMID: 28669844 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 5, 2016
• Study Start: February 1, 2015
• Primary Completion: July 1, 2016
• Last Updated: October 5, 2016

Record last verified: 2016-10