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临床试验/NCT07455448
NCT07455448已完成不适用

Antibiotic Resistance of Helicobacter Pylori in Nanjing: A Cross-Sectional Study

Nanjing First Hospital, Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 7,227 人开始时间: 2026年3月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
7,227
试验地点
1
主要终点
Phenotypic Antibiotic Resistance Rate

研究概览

简要总结

This study aims to provide an updated analysis of the resistance patterns of H. pylori in the Nanjing region, with a focus on characterizing the current status of phenotypic and genotypic resistance to these six antimicrobial agents. The findings are expected to offer a scientific basis for the rapid diagnosis and personalized treatment of H. pylori infection.

详细描述

Since its discovery, Helicobacter pylori has become one of the most prevalent microorganisms globally, with an estimated worldwide infection rate of 44.3%. The burden is notably higher in developing countries (50.8%) compared to developed nations (34.7%). Beyond its established role in chronic active gastritis and peptic ulcer disease, H. pylori is now recognized as a primary risk factor for gastric cancer and mucosa-associated lymphoid tissue lymphoma. This is particularly significant in China, where gastric cancer ranks as a leading malignancy. Consequently, H. pylori infection constitutes a major public health challenge. The escalating threat of antimicrobial resistance further underscores the urgent need to improve eradication strategies. The Maastricht VI/Florence Consensus Report recommends routine antibiotic susceptibility testing to guide the selection of precise treatment regimens prior to H. pylori eradication. Currently, only a limited number of antibiotics-including amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline, and furazolidone-remain effective. However, their widespread use has accelerated the emergence of resistance. China, with its high burden of infection, faces a particularly complex landscape of antibiotic resistance.

Regimens containing clarithromycin and levofloxacin are effective strategies for both first-line and salvage therapy. A meta-analysis highlighted that a 14-day levofloxacin-based sequential therapy is one of the most effective regimens worldwide. However, levofloxacin susceptibility shows significant geographic variation, with primary resistance rates in China having risen considerably in recent years. Faced with continuously rising resistance rates to these antibiotics, it is crucial to delineate the dynamic trends in phenotypic resistance and the characteristics of associated gene mutations.

The increasingly severe resistance situation necessitates the establishment of continuous surveillance and the accumulation of local data. Our center has previously published cross-sectional studies analyzing H. pylori resistance in Nanjing. However, data on resistance trends for other antimicrobials and their potential mechanisms remain limited. Therefore, this study systematically reviews the evolution of phenotypic and genotypic resistance rates of H. pylori to six commonly used antibiotics over the past seven years.

Beyond phenotypic analysis, this study investigates the genotypic resistance mechanisms for these antibiotics. Resistance in H. pylori primarily results from mutations in genes encoding drug targets, leading to reduced efficacy. Evidence indicates that susceptibility can be effectively assessed by detecting specific mutations: in the 23S rRNA gene (e.g., A2143G, A2142G) for clarithromycin resistance; the gyrA gene for quinolone resistance; penicillin-binding protein genes for amoxicillin resistance; the 16S rRNA gene for tetracycline resistance; and the rdxA and frxA genes for metronidazole resistance.

Objective and Methods This retrospective, single-center, cross-sectional epidemiological study aims to provide an updated analysis of H. pylori resistance patterns in the Nanjing region. It focuses on characterizing the current status of phenotypic and genotypic resistance to amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline, and furazolidone. The findings are intended to provide a scientific basis for the rapid diagnosis and personalized treatment of H. pylori infection. The study involves a retrospective review of medical records from the electronic medical record system and laboratory information system of Nanjing First Hospital. It will identify all outpatients who underwent H. pylori culture and genetic testing at the gastroenterology clinic between January 1, 2018, and December 31, 2025.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who visited the Gastroenterology Department of Nanjing First Hospital and underwent gastroscopy with H. pylori culture and genetic testing between 2018 and
  • Positive for H. pylori by at least one diagnostic method (13C-urea breath test, rapid urease test, or histopathology).
  • Provision of general written informed consent for the use of gastroscopy and specimen data in research.
  • Availability of complete medical records and laboratory test results.

排除标准

  • Withdrawal of informed consent; use of antibiotics, proton pump inhibitors, H2-receptor antagonists, or bismuth agents within four weeks prior to gastroscopy.
  • History of gastric surgery.
  • Incomplete medical records or test results precluding evaluation.
  • Other factors deemed by the investigator to render the participant unsuitable for inclusion.

结局指标

主要结局

Phenotypic Antibiotic Resistance Rate

时间窗: April to May 2026

Description: Resistance rate for each antibiotic (amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline, and furazolidone) as determined by phenotypic antimicrobial susceptibility testing. Unit of Measure: Percentage (%) Aggregation: Resistance rate will be calculated as the number of patients resistant to a specific antibiotic divided by the total number of patients tested for that antibiotic.

次要结局

  • Genotypic Mutation Rate(April to May 2026)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhenyu Zhang

Chief Physician

Nanjing First Hospital, Nanjing Medical University

研究点 (1)

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