Efficacies of Tetracycline-levofloxacin Quadruple Therapy, Standard Bismuth Quadruple Therapy and Amoxicillin-levofloxacin Quadruple Therapy in the Second-line Treatment of H Pylori Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- the rate of Helicobacter pylori
研究概览
简要总结
- Compare the efficacy of "Tetracycline combined with levofloxacin quadruple therapy", "standard tincture quadruple therapy" and "amoxicillin combined with levofloxacin quadruple therapy" on the second line of Helicobacter pylori sterilization.
- To investigate the drug resistance of Helicobacter pylori and the host genotypes of CYP2C19 and IL-1B-511 on the sterilizing effect of three second-line Helicobacter pylori.
详细描述
The "standard tincture quadruple therapy" and the "proton pump inhibitor combined with fluoroquinolone and amoxicillin triple therapy" recommended by the 5th Mazdock-Florence Consensus Conference on the second line of Helicobacter pylori treatment The sterilization rate is not ideal (less than 80%). Recently, we have developed a "Tetracycline combined with levofloxacin quadruple therapy" for first-line treatment failure of H. pylori infection, with a relatively high sterilization rate (> 95%). A randomized controlled trial confirmed that the elimination rate of "Tetracycline combined with levofloxacin quadruple therapy" was better than "proton pump inhibitor combined with fluoroquinolone" after "standard triple therapy" and "non-tank tetratherapy" sterilization failure. Triple therapy with amoxicillin.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 20 years old
- •subject was failure for the first line therapy of Helicobacter pylori
排除标准
- •Those who are allergic to the drugs used in this study
- •Those who have had a stomach surgery
- •Those who have antibiotics within four weeks of treatment
- •Those who have severe cirrhosis, uremia or malignancy
- •Those who are a pregnant woman or a woman who breastfeeds
研究组 & 干预措施
Tetracycline combined with levofloxacin quadruple therapy
esomeprazole 40mg twice a day + tripotassium dicitrate bismuthate 300mg four times a day+ tetracycline 500mg four times a day+ levofloxacin 500mg once a day
干预措施: esomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacin (Drug)
standard tincture quadruple therapy
esomeprazole 40mg twice a day + tripotassium dicitrate bismuthate 300mg four times a day
- tetracycline 500mg four times a day + metronidazole 250mg four times a day
干预措施: esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazole (Drug)
amoxicillin combined with levofloxacin quadruple therapy
esomeprazole 40mg twice a day + tripotassium dicitrate bismuthate 300mg four times a day+ amoxicillin 500mg four times a day+ levofloxacin 500mg once a day
干预措施: esomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacin (Drug)
结局指标
主要结局
the rate of Helicobacter pylori
时间窗: 6 week after finish study drugs
evalute eradication outcome by 13C urea breath test
次要结局
- genotype analysis(2 weeks after finishing study drgus)
研究者
DENG-CHYANG WU
clinical professor
Kaohsiung Medical University