Prevalence and Trends of Antimicrobial Resistance of Helicobacter Pylori in Korea

To assess antimicrobial resistance rates and minimal inhibitory concentrations in H. pylori isolated from patients with upper gastrointestinal disease with long-term period.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection; Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation; Helicobacter Pylori Associated Gastrointestinal Disease; Helicobacter Pylori Infection, Susceptibility to

Detailed Description

Failure of eradication treatment against Helicobacter pylori (H. pylori) is mainly caused by antimicrobial resistance. However, there is no relevant studies have been conducted on the prevalence and trend of antimicrobial resistance, which is considered to have a major determinant of eradication failure. In addition, studying the trend of resistance rate is an important basis for establishing an appropriate strategy for eradication treatment in the future.

Patients who had H. pylori colonies isolated from culture were consecutively enrolled from 2003. From each patient, 1 to 10 H. pylori isolates were isolated. Trends in MIC distribution and prevalence of resistance were investigated for each antimicrobial agent according to time period. Antimicrobi resistances suspected to related with failure of empirical PPI triple, quadruple, and rescue fluoroquinolone-containing treatment were also investigated. Multiple resistance, which is simultaneously resistant to various antibiotics, will also be investigated. Risk factors for the antibiotic resistance will be analyzed.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Jung Won Lee, M.D.; Phone Number: + 82-10-9356-7758; Email: saludos@naver.com
• Study Contact Backup: Name: Nayoung Kim, M.D., Ph.D.; Phone Number: + 82-31-787-7008; Email: nakim49@snu.ac.kr

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
      • Principal Investigator: Nayoung Kim, M.D.,Ph.D.
      • Contact: Nayoung Kim; Phone Number: 82317877009; Email: nayoungkim49@empas.com
      • Contact: Phone Number: 821052164932

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The subjects of this study all had H. pylori infection. None of them should meet the exclusion criteria. Even though successfully proven H. pylori infection, culture procedures must be successful and the susceptibility must be clearly determined by obtaining MIC values to be finally included in this study. According to the literature, culture is successful at approximately 2/3. Informed consent will be obtained from all study subjects.

Description

Inclusion Criteria:

• Subjects who had a H. pylori infection and had consented to undergo culture analysis via endoscopic resection, in order to determine the minimal inhibitory concentration (MIC) of various antibiotics.

Exclusion Criteria:

• Patients with a concurrent critical illness, who abused drugs or alcohol, who were pregnant or nursing, or those who had received antibiotics, PPIs, or bismuth salts within 4 weeks, were excluded.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resistance rate	It means resistance to an antimicrobial agent applicable for H. pylori eradication. Minimal inhibitory concentration test was performed for amoxicillin, clarithromycin, metronidazole, tetracycline, rifabutin, levofloxacin, and moxifloxacin using agar dilution method.	through study completion, an average of 1 year
Minimal inhibitory concentration (MIC) distribution	The concentration of specific antibiotics that can kill 50% of H. pylori is defined as MIC50. Each analyzes the ratio of strain according to the concentration of antibiotics.	through study completion, an average of 1 year
Multiple resistance, prevalance and trends	It is defined as the case where the H. pylori strain shows resistance to several antimicrobial agents at the same time. Multiple resistance is calculated by calculating the proportion of strains with simultaneous resistance to 1> clarithromycin and metronidazole, 2> clarithromycin and fluoroquinolone, and 3> clarithromycin, fluoroquinolone, and metronidazole.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factor for eradication failure or success	Risk factors for eradication failure or success could be found in the demographic profile of the study subject along with resistance/non-resistance to each antibiotic to H. pylori and its strain. According to previous studies, risk factors related with eradication failure or success are usually known from demographic data such as age, sex, and history of eradication treatment. In our study, we use logistic regression analysis to find out whether these factors have significance.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Study Chair: Nayoung Kim, M.D., Ph.D, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2003
• Primary Completion (Anticipated): December 31, 2027
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Helicobacter pylori; antibiotics; resistance; eradication; rescue therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Gastrointestinal Diseases; Digestive System Diseases; Disease Susceptibility; Helicobacter Infections
• Other Study ID Numbers: B-1504-294-305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No