Optimal Duration of Antimicrobial Susceptibility Test (AST) Guided Rescue Therapy for Helicobacter Pylori Infection
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 700
- 主要终点
- The different rate of H. pylori eradication among 3 different course of treatments (7-day, 10-day and 14-day) guided by AST in per-protocol (PP) analysis.
研究概览
简要总结
Strongly evidence supports that H. pylori eradication is an effective approach to reduce the incidence of those pathologies. However, due to the increasing resistance rates to antibiotics, failures of H. pylori eradication get more and more common. Thus, rescue therapy for persistent H. pylori infection is becoming a grand challenge the investigators have to face.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients require upper endoscopy owing to persistent H. pylori infection despite one or more treatment attempts.
排除标准
- •Age younger than 18 years;
- •Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
- •Known or suspected allergy to study medications;
- •Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
结局指标
主要结局
The different rate of H. pylori eradication among 3 different course of treatments (7-day, 10-day and 14-day) guided by AST in per-protocol (PP) analysis.
时间窗: 9 months
The different rate of H. pylori eradication among 3 different course of treatments (7-day, 10-day and 14-day) guided by AST in intention-to-treat (ITT) analysis.
时间窗: 9 months
次要结局
- the rate of adverse events happening(9 months)
- the rate of improving dyspepsia symptoms after H. pylori eradication(9 months)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University