Rifabutin-containing Triple Therapy for Helicobacter Pylori Rescue Treatment: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 3
- 主要终点
- Helicobacter pylori eradication rate
研究概览
简要总结
Dual therapy containing vonoprazan and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined its efficacy for H. pylori rescue treatment. Rifabutin has low antibiotic resistance, superior antibacterial activity in vitro, and stability in the gastric acid environment. Several studies have confirmed the efficacy of rifabutin-containing triple therapy as a first-line or rescue treatment for H. pylori. The purpose of this study was to evaluate the efficacy and safety of dual therapy vesus rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori.
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
- •Ability and willingness to participate in the study and to sign and give informed consent
- •Confirmed H. pylori infection and with previous treatment experience
排除标准
- •subjects naive to H. pylori treatment,
- •under 18 or over 80 years old
- •history of gastrectomy
- •pregnant or lactating women
- •Previous history of tuberculosis
- •Allergy to any of the study drugs
- •severe systemic diseases or malignancy
- •administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
研究组 & 干预措施
Tetracycline Bismuth Quadruple Therapy
Vonoprazan 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid
干预措施: Vonoprazan (Drug)
Tetracycline Bismuth Quadruple Therapy
Vonoprazan 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid
干预措施: Bismuth Potassium Citrate (Drug)
Tetracycline Bismuth Quadruple Therapy
Vonoprazan 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid
干预措施: Tetracycline (Drug)
Tetracycline Bismuth Quadruple Therapy
Vonoprazan 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid
干预措施: Metronidazole (Drug)
Rifabutin Triple Therapy
Vonoprazan 20mg bid, amoxicillin 1000mg tid, rifabutin 150mg bid
干预措施: Vonoprazan (Drug)
Rifabutin Triple Therapy
Vonoprazan 20mg bid, amoxicillin 1000mg tid, rifabutin 150mg bid
干预措施: Amoxicillin (Drug)
Rifabutin Triple Therapy
Vonoprazan 20mg bid, amoxicillin 1000mg tid, rifabutin 150mg bid
干预措施: Rifabutin (Drug)
Dual Therapy
Vonoprazan 20mg bid, amoxicillin 1000mg tid
干预措施: Vonoprazan (Drug)
Dual Therapy
Vonoprazan 20mg bid, amoxicillin 1000mg tid
干预措施: Amoxicillin (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
- Compliance rate(Within 7 days after completion of therapy)
- Rate of adverse effects(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