Prevalence and Trends of Antimicrobial Resistance of Helicobacter Pylori in Korea

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05247112

Collaborator

(none)

2,000

Enrollment

Location

294

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection Helicobacter Pylori Associated Gastrointestinal Disease Helicobacter Pylori Infection, Susceptibility to Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation

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 Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Prevalence and Trends of Antimicrobial Resistance of Helicobacter Pylori in Korea

Actual Study Start Date :

Jul 1, 2003

Anticipated Primary Completion Date :

Dec 31, 2027

Anticipated Study Completion Date :

Dec 31, 2027

Outcome Measures

Primary Outcome Measures

Resistance rate [through study completion, an average of 1 year]
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.
Minimal inhibitory concentration (MIC) distribution [through study completion, an average of 1 year]
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.
Multiple resistance, prevalance and trends [through study completion, an average of 1 year]
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.

Secondary Outcome Measures

Risk factor for eradication failure or success [through study completion, an average of 1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.