Helicobacter Pylori Rescue Treatment Containing Tetracycline in Patients Allergic to Penicillin:a Prospective Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 250
- 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 and compare the effectiveness of furazolidone-tetracycline-containing and tinidazole-tetracycline-containing quadruple regimens for the rescue treatment of Helicobacter pylori infection in patients allergic to penicillin.
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 pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathologies.However,Helicobacter pylori eradication is a challenge in patients allergic to penicillin. Therefore, the investigators aim to assess and compare the effectiveness of furazolidone-tetracycline-containing and tinidazole-tetracycline-containing quadruple regimens for the rescue treatment of Helicobacter pylori infection in patients allergic to penicillin.
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
- Double (Investigator, Outcomes Assessor)
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 Helicobacter pylori eradication.
- •Patients Allergic to Penicillin.
排除标准
- •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
furazolidone-tetracycline-containing quadruple
patients in furazolidone-tetracycline-containing quadruple group will receive Esomeprazole 40mg po bid, tetracycline 500mg po qid , bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and furazolidone 100mg po bid for 14d
干预措施: Furazolidone (Drug)
tinidazole-tetracycline-containing quadruple group
patients in tinidazole-tetracycline-containing quadruple group will receive Esomeprazole 40mg po bid, tetracycline 500mg po qid , bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and tinidazole 500mg po tid for 14d.
干预措施: Tinidazole (Drug)
结局指标
主要结局
Eradication rates in 2 groups
时间窗: 12months
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 who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
次要结局
- The rate of improving dyspepsia symptoms after Helicobacter pylori eradication(12months)
- The rate of adverse events happening(12months)
- The rate of good compliance(12months)
研究者
Xiuli Zuo
director of Qilu Hospital gastroenterology department
Shandong University