Comparison of Helicobacter Pylori Treatment Between Modified Quadruple Therapy and Tailored Eradication Based on the Presence of Clarithromycin Resistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- H. pylori infection status
研究概览
简要总结
The rate of H. pylori resistance to antimicrobial agents including clarithromycin (CAM) has increased worldwide. Eradication failure using triple therapy is strongly associated with CAM-resistant H. pylori. The tailored therapy is defined as a targeted H. pylori eradication which emphasizes on predicting individual drug responses before treatment.
Dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) was developed to diagnose H. pylori infection and identify CAM resistance. The use of DPO-PCR has increased the tailored H. pylori eradication rate in Korea. If DPO-PCR testing is not available, a 14-day modified bismuth-containing quadruple regimen is recommended as a first-line H. pylori eradication. However, there is no comparison study between modified quadruple therapy and tailored eradication based on the presence of CAM resistance using DPO-PCR.
详细描述
The investigators aim to evaluate the success rate, adverse drug events, and cost-effectiveness of modified quadruple therapy, compared with tailored eradication based on the presence of CAM resistance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastroscopy can be performed
- •H. pylori test and pathological analysis can be performed
排除标准
- •Age < 20 or > 80 years
- •Anemia (serum hemoglobin level < 10 g/dL)
- •Severe systemic disease
- •Advanced chronic liver disease
- •Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
- •History of H. pylori eradication
- •History of gastric surgery
- •Recent history of upper gastrointestinal bleeding
研究组 & 干预措施
Modified quadruple therapy
pantoprazole 40mg bid, amoxicillin 1000mg bid, metronidazole 750mg bid, bismuth subcitrate 600mg bid for 14 days
干预措施: H. pylori eradication (Drug)
Tailored eradication
pantoprazole 40mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid or pantoprazole 40mg bid, tetracycline 1000mg bid, metronidazole 750mg bid, bismuth subcitrate 600mg bid for 7 days
干预措施: H. pylori eradication (Drug)
结局指标
主要结局
H. pylori infection status
时间窗: 6 weeks
Rate of successful H. pylori eradication
次要结局
未报告次要终点
研究者
Jun-Hyung Cho
Associate Professor
Soonchunhyang University Hospital