14-Day Antimicrobial Susceptibility Testing Guided Therapy Versus Personal Medication History Guided Therapy as a Rescue Treatment of Helicobacter Pylori Infection-A Randomized Controlled Trail
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Eradication rates in 2 groups
研究概览
简要总结
The purpose of this study is to assess efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection, then comparing it with 14-day personal medication history guided therapy to tell which one has a better performance in both efficacy and safety.
详细描述
Helicobacter pylori (H.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathology, especially non-cardiac gastric cancer. Strong evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathological processes. Antimicrobial susceptibility test can pick out sensitive drugs to kill Helicobacter pylori, and reduce secondary drug resistance. But, there is a lack of high quality RCT to compare its efficacy with empirical regimen in the rescue treatment.
This study aims to assess the efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection. Comparing this regimen with 14-day personal Medication History guided therapy to tell which one is better in clinic practice. Alterations in H.pylori assosicated dyspepsia and safety outcomes will also be evaluated.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-70 with H. pylori infection. Patients with previous H. pylori eradication therapy for one or two times.
排除标准
- •Patients unable or unwilling to receive gastroscopy; Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks; Patients with gastrectomy, acute GI bleeding and advanced gastric cancer; Patients with known or suspected allergy to study medications; Currently pregnant or lactating; Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
研究组 & 干预措施
Antimicrobial susceptibility testing guided therapy
14d bismuth quadruple therapy based on susceptibility test.
干预措施: susceptibility guided therapy (Drug)
Personal medication history guided therapy
14d bismuth quadruple therapy based on previous medication history.
干预措施: personal medication history guided therapy (Drug)
Salvage therapy for negative culture
14d bismuth quadruple therapy based on previous medication history.
干预措施: personal medication history guided therapy (Drug)
Salvage therapy for failed eradication
14d bismuth quadruple therapy for salvage treatment.
干预措施: salvage treatment for failed eradication (Drug)
结局指标
主要结局
Eradication rates in 2 groups
时间窗: 6 months
Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients. The PP analysis is limited to patients who take over 80% of the study medications and complete follow-up.
次要结局
- The rate of improving dyspepsia symptoms after Helicobacter pylori eradication.(6 months)
研究者
Xiuli Zuo
director of Qilu Hospital gastroenterology department
Shandong University