Prevalence and Trends of Antimicrobial Resistance of Helicobacter Pylori in Korea

Helicobacter Pylori Infection Clinical Trial

Official title:

Prevalence and Trends of Antimicrobial Resistance of Helicobacter Pylori in Korea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05247112
• Other study ID #: B-1504-294-305
• Status: Recruiting
• Start date: July 1, 2003
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2023
• Source: Seoul National University Bundang Hospital
• Contact: Jung Won Lee, M.D.
• Phone: + 82-10-9356-7758
• Email: saludos[@]naver.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Digestive System Diseases
• Disease Susceptibility
• Gastrointestinal Diseases
• Helicobacter Infections
• Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation
• Helicobacter Pylori Infection
• Infections

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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