Optimal Tailored Treatment for H. Pylori Infection According to the Presence of DPO-PCR Based Clarithromycin Resistance
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Eradication success
研究概览
简要总结
The efficacy of the current standard triple therapy is at an unacceptably low level. Resistance to antibiotics is suspected to be the major cause of the low efficacy of standard triple therapy. Point mutations in the 23S rRNA gene are known to be the primary mechanism of clarithromycin resistance against H pylori. Recently, a point mutation detection kit using a dual-priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) assay was introduced and made commercially available. The primary goal of our study was to compare the eradication rates of empirical therapy and tailored therapy. Specifically we examined the eradication rates of 7-d, 14-d empirical therapy with 7-d, 14-d tailored therapy. Our secondary goal was to examine the adverse events of each treatment, cost effectiveness of each treatment methods, and accuracy of DPO-PCR for detecting H. pylori resistance.
详细描述
Patients are randomly assigned to the empirical therapy group and tailored therapy group.
The empirical therapy group recieves triple therapy of 7 or 14 days. The tailored therapy group receives treatment based on their DPO-PCR results.
Patients who are sensitive to clarithromycin based on DPO-PCR receives triple therapy for 7 or 14 days. Patients who are resistant to clarithromycin based on DPO-PCR recieves bismuth quadruple therapy for 7 or 14 days.
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
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •consecutive subjects who underwent upper gastrointestinal endoscopy and who had a confirmed diagnosis of H pylori infection
排除标准
- •subjects younger than 18 years old
- •subjects with a history of H pylori eradication
- •subjects who had previous gastric surgery
- •subjects who were pregnant or lactating
- •subjects with serious concurrent illness
- •subjects who were administered antibiotics, bismuth, or PPIs in the 8 weeks preceding the study
- •subjects with a history of allergy to any one of the compounds in this study
结局指标
主要结局
Eradication success
时间窗: 8-12 weeks after eradication
H. pylori eradication success based on urea breath test
次要结局
未报告次要终点
研究者
Joon Sung Kim
Assistant Proffessor
Incheon St.Mary's Hospital