Clarithromycin-, Metronidazole-, or Levofloxacin-containing Therapy for Helicobacter Pylori-infected Penicillin-allergic Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 504
- 试验地点
- 1
- 主要终点
- Eradication rate of Helicobacter pylori
研究概览
简要总结
This randomized controlled clinical trial will compare the eradication efficacy of bismuth quadruple therapy containing clarithromycin+metronidazole, clarithromycin+levofloxacin, or metronidazole+levofloxacin for Helicobacter pylori first-line treatment in penicillin-allergic patients. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
- •18-75 years old on the day of signing the ICF.
- •Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
- •Have not received Helicobacter pylori eradication treatment before.
- •allergic to penicillin.
排除标准
- •Have received Hp eradication treatment.
- •Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
- •Subjects or guardians refused to participate in the trial.
- •Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
- •Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional medicine 4 weeks before treatment.
- •Pregnant or lactating women.
- •Active peptic ulcer.
- •allergic to drugs used in the trial.
- •any other circumstances that are not suitable for recruitment.
研究组 & 干预措施
CL group
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levoflaxacin 0.5 g qd for 14 days
干预措施: Rabeprazole (Drug)
CL group
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levoflaxacin 0.5 g qd for 14 days
干预措施: Bismuth potassium citrate (Drug)
CL group
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levoflaxacin 0.5 g qd for 14 days
干预措施: Clarithromycin (Drug)
CL group
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levoflaxacin 0.5 g qd for 14 days
干预措施: Levofloxacin (Drug)
LM group
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levoflaxacin 0.5 g bid for 14 days
干预措施: Rabeprazole (Drug)
LM group
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levoflaxacin 0.5 g bid for 14 days
干预措施: Bismuth potassium citrate (Drug)
LM group
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levoflaxacin 0.5 g bid for 14 days
干预措施: Metronidazole (Drug)
LM group
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levoflaxacin 0.5 g bid for 14 days
干预措施: Levofloxacin (Drug)
CM group
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days
干预措施: Rabeprazole (Drug)
CM group
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days
干预措施: Bismuth potassium citrate (Drug)
CM group
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days
干预措施: Metronidazole (Drug)
CM group
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days
干预措施: Clarithromycin (Drug)
结局指标
主要结局
Eradication rate of Helicobacter pylori
时间窗: At least 4 weeks after completion of therapy
Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value).
次要结局
- Eradication rate of Helicobacter pylori susceptible strains(At least 4 weeks after completion of therapy)
- Eradication rate of Helicobacter pylori resistant strains(At least 4 weeks after completion of therapy)