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临床试验/NCT03583476
NCT03583476Unknown不适用

The Impact of Antibiotics MIC Value on the Efficacy of Treatment Regimens for Helicobacter Pylori Infection.

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 1,821 人开始时间: 2018年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
1,821
试验地点
1
主要终点
Relationship between eradication rate (%) of therapy regimen and influencing factors (eg. sex, age, diagnosis, MIC).

研究概览

简要总结

Clarithromycin (CLA)、amoxicillin (AMO)、metronidazole (MET)、levofloxacin (LEV) and tetracycline (TET) are commonly used antibiotics for Helicobacter pylori (Hp) therapy. However, the efficacy of treatment for Helicobacter pylori infection has decreased due to increasing resistance to CLA, MET and LEV. Studies had reported that beside antibiotics resistance, other factors such as age, sex, underlying disease, etc. may also affect the treatment efficacy. In some cases, when the MIC values were beyond the breakpoint, H. pylori strains with lower MIC value had better eradication than the ones with higher MIC value. However, few study investigated the relationship between MIC values and treatment outcome.

The investigators aimed to analyze the impact of influencing factors, especially minimal inhibitory concentration (MIC) value, on the efficacy of different treatment regimens.

研究设计

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

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients (aged ≥ 20 years old) with H. pylori infection between Jan. 1994 to Mar. 2018

排除标准

  • without antibiotics susceptible test result, without treatment outcome, history of any gastrointestinal surgery, serious concomitant (renal failure, liver cirrhosis, heart failure and disease need immunosuppressant for therapy.

研究组 & 干预措施

CLA triple therapy

Patients with clarithromycin-containing triple therapy

干预措施: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole (Drug)

MET triple therapy

Patients with metronidazole-containing triple therapy

干预措施: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole (Drug)

Concomitant therapy

Patients with concomitant therapy

干预措施: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole (Drug)

Sequential therapy

Patients with sequential therapy

干预措施: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole (Drug)

结局指标

主要结局

Relationship between eradication rate (%) of therapy regimen and influencing factors (eg. sex, age, diagnosis, MIC).

时间窗: 4 weeks after treatment finished.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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