Genotypic Resistance Guided Therapy in the Treatment of Helicobacter Pylori Infection
试验速览
- 阶段
- 4 期
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Eradication rate after third line rescue therapy
研究概览
简要总结
We aimed to compare the efficacy of genotypic resistance guided sequential therapy vs. empiric therapy in the third line therapy. Factors affecting the eradication rates, including the antibiotic resistance, CYP2C19 polymorphism, CagA and VacA status will also be assessed.
详细描述
The primary aim of this study is to compare the regimens selected using either one of the method (1) genotypic resistance guided versus (2) medication history guided therapy. (rather than to compare the efficacy of any drugs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged greater than 20 years who have persistent H. pylori infection after at least two treatments and are willing to receive third line rescue regimens are considered eligible for enrollment.
排除标准
- •Patients will be excluded from the study if any one of the following criteria is present: (1) children and teenagers aged less than 20 years, (2) history of gastrectomy, (3)gastric malignancy, including adenocarcinoma and lymphoma, (4) previous allergic reaction to antibiotics (Amoxicillin, Klaricid, Cravit) and prompt pump inhibitors (esomeprazole), (5)contraindication to treatment drugs, (6) pregnant or lactating women, (7) severe concurrent disease.
研究组 & 干预措施
Empirical therapy
selection of antibiotic according to medication history
干预措施: empirical therapy (Drug)
Genotypic resistance guided therapy
selection of antibiotics according to genotypic resistance
干预措施: Genotypic resistance guided therapy (Drug)
结局指标
主要结局
Eradication rate after third line rescue therapy
时间窗: 8 weeks
Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) and per-protocol (PP) analyses. (genotypic resistance versus empirical therapy) Urea breath test will be used to determine the eradication status
次要结局
- eradication rates in subgroup analysis by antibiotic resistance and regimen(8 weeks)
研究者
National Taiwan University Hospital
Doctor
National Taiwan University Hospital