Rescue Therapy for Helicobacter Pylori Eradication: a Randomized Non-Inferiority Trial of Minocycline or Tetracycline in Bismuth Quadruple Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 368
- 试验地点
- 3
- 主要终点
- Helicobacter pylori eradication rate
研究概览
简要总结
Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy in which tetracycline was replaced by minocycline.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability and willingness to participate in the study and to sign and give informed consent
- •Confirmed H. pylori infection and with previous treatment failure
排除标准
- •subjects naive to H. pylori treatment,
- •under 18 or over 80 years old
- •history of gastrectomy
- •pregnant or lactating women
- •severe systemic diseases or malignancy
- •administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
- •contraindications to the study drugs
研究组 & 干预措施
Tetracycline Bismuth Quadruple Therapy
Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Tetracycline 500mg qid Metronidazole 400mg qid
干预措施: Esomeprazole (Drug)
Tetracycline Bismuth Quadruple Therapy
Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Tetracycline 500mg qid Metronidazole 400mg qid
干预措施: Bismuth Potassium Citrate (Drug)
Tetracycline Bismuth Quadruple Therapy
Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Tetracycline 500mg qid Metronidazole 400mg qid
干预措施: Tetracycline,Metronidazole (Drug)
Minocycline Bismuth Quadruple Therapy
Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Minocycline 100mg bid Metronidazole 400mg qid
干预措施: Esomeprazole (Drug)
Minocycline Bismuth Quadruple Therapy
Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Minocycline 100mg bid Metronidazole 400mg qid
干预措施: Bismuth Potassium Citrate (Drug)
Minocycline Bismuth Quadruple Therapy
Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Minocycline 100mg bid Metronidazole 400mg qid
干预措施: Minocycline,Metronidazole (Drug)
结局指标
主要结局
Helicobacter pylori eradication rate
时间窗: Six weeks after completion of therapy
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).
次要结局
- Rate of adverse effects(Within 7 days after completion of therapy)
- Compliance rate(Within 7 days after completion of therapy)
研究者
Hong Lu, MD
Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine
RenJi Hospital