Clinical trial NCT05247112: Prevalence and Trends of Antimicrobial Resistance of Helicobacter Pylori in Korea
Official title: Prevalence and Trends of Antimicrobial Resistance of Helicobacter Pylori in Korea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Helicobacter Pylori Infection
Helicobacter Pylori Associated Gastrointestinal Disease
Helicobacter Pylori Infection, Susceptibility to
Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation
Keywords: eradication
rescue therapy
antibiotics
resistance
Helicobacter pylori
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Resistance rate
timeFrame: through study completion, an average of 1 year
measure: Minimal inhibitory concentration (MIC) distribution
timeFrame: through study completion, an average of 1 year
measure: Multiple resistance, prevalance and trends
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Risk factor for eradication failure or success
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Nayoung Kim, M.D., Ph.D
role: STUDY_CHAIR
References: