Helicobacter Pylori Antibiotic Susceptibility Testing of Korea

Sponsor
Asan Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02961296
Collaborator
National Evidence-Based Healthcare Collaborating Agency (Other)
400
1
26
15.4

Study Details

Study Description

Brief Summary

The purpose of this study is to make nationwide registry for antimicrobial resistance of Helicobacter pylori using single method with agar dilution in Korea.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Detailed Description

Backgrounds:

The success rate of Helicobacter pylori eradication in Korea is not sufficient in recent days. The main cause of eradication failure is known as antimicrobial resistance and previous studies showed that resistant rates were different according to the regions in Korea. However, until now, there are not enough studies about the nationwide results for antimicrobial resistance and previous reports used various methods for the resistant test.

Theories and Plans:

The nationwide resistant registry of Helicobacter pylori using standardized single method, agar dilution test, can be useful for the development of new eradication methods to make eradication rate higher. Moreover, the higher rate of Helicobacter pylori eradication can reduce the chance of gastric cancer and also can reduce the medical expenses.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
400 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Helicobacter Pylori Antibiotic Susceptibility Testing of Korea
Study Start Date :
Oct 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Dec 1, 2018

Outcome Measures

Primary Outcome Measures

  1. The rate of exceeding the resistance criteria in Helicobacter pylori(H. pylori) antibiotic susceptibility test(Agar dilution method) [6 more days]

    The resistance criterion specifies that Clarithromycin is excess of 1.0 μg/mL, Amoxicillin is excess of 0.5 μg/mL, Metronidazole is excess of 8 μg/mL, Tetracycline is excess of 4 μg/mL, Levofloxacin is excess of 1 μg/mL and Ciprofloxacin is excess of 1 μg/mL. All of resistance criteria follow a criteria of NCCLS(National Committee for Clinical Laboratory Standards)

Secondary Outcome Measures

  1. The gap of the rate of the antibiotic resistance to H. pylori by regional groups [6 more days]

  2. The success rate of H. pylori strain separation [6 more days]

    Analyze the case of inseparable H. pylori strain and the reason of failure for culture after H. pylori strain separation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Aged 19 to 79 year person who need the examination of Helicobacter pylori infection during upper gastrointestinal endoscopy.

  • No history of Helicobacter pylori eradication.

  • No history of antibiotics within one month.

  • Person who agree on the consent.

Exclusion Criteria:
  • History of antibiotics more than 3 days sequentially within one month.

  • History of subtotal gastrectomy.

  • Person who does not agree on the consent.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center Seoul Korea, Republic of 05505

Sponsors and Collaborators

  • Asan Medical Center
  • National Evidence-Based Healthcare Collaborating Agency

Investigators

  • Principal Investigator: Hwoon-Yong Jung, Professor, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hwoon-Yong Jung, Professor, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT02961296
Other Study ID Numbers:
  • AMC 2016-0467
First Posted:
Nov 10, 2016
Last Update Posted:
Nov 10, 2016
Last Verified:
Nov 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Hwoon-Yong Jung, Professor, Asan Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 10, 2016