Efficacy of Two Antimicrobial Susceptibility Testing Guided Antibiotic Selection Strategies in Salvage Helicobacter Pylori Treatment
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Eradication rates in 2 groups
研究概览
简要总结
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.
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
- •Consecutive patients who are 18-70 years old with persistent H. pylori infection after first or second line treatment attempts.
排除标准
- •Enable to undergo upper endoscopy;
- •Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
- •Known or suspected allergy to study medications;
- •Taking bismuth and antibiotics in the previous four weeks, or taking proton pump inhibitor and H2-receptor blockers in the previous two weeks;
- •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
clarithromycin dependant group
Patients in this group will receive 14-day bismuth-based quadruple therapies guided by the susceptibility of clarithromycin. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d.
The kinds of 2 antibiotics will be depend on the susceptibility of clarithromycin.
If clarithromycin is susceptible, amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d will be chosen; If clarithromycin is resistant, amoxicillin 1 g bid and furazolidone 100 mg b.i.d will be chosen.
干预措施: Clarithromycin susceptibility dependant strategy (Drug)
clarithromycin dependant group
Patients in this group will receive 14-day bismuth-based quadruple therapies guided by the susceptibility of clarithromycin. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d.
The kinds of 2 antibiotics will be depend on the susceptibility of clarithromycin.
If clarithromycin is susceptible, amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d will be chosen; If clarithromycin is resistant, amoxicillin 1 g bid and furazolidone 100 mg b.i.d will be chosen.
干预措施: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin (Drug)
clarithromycin dependant group
Patients in this group will receive 14-day bismuth-based quadruple therapies guided by the susceptibility of clarithromycin. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d.
The kinds of 2 antibiotics will be depend on the susceptibility of clarithromycin.
If clarithromycin is susceptible, amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d will be chosen; If clarithromycin is resistant, amoxicillin 1 g bid and furazolidone 100 mg b.i.d will be chosen.
干预措施: amoxicillin and clarithromycin or amoxicillin and furazolidone (Drug)
6 antibiotics dependant group
Patients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, a bismuth and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.
Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d.
干预措施: 2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline ) (Drug)
6 antibiotics dependant group
Patients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, a bismuth and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.
Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI). The dose of colloidal bismuth pectin is 200 mg b.i.d.
干预措施: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin (Drug)
salvage therapy for negative culture
when the results of culture are negative, patients will receive Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, Colloidal Bismuth Pectin 200 mg (IAFB regimen) or Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, tetracycline 750 mg (IAFT regimen)，all are used twice daily except tetracycline which is taken 3 times daily.
干预措施: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin (Drug)
salvage therapy for negative culture
when the results of culture are negative, patients will receive Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, Colloidal Bismuth Pectin 200 mg (IAFB regimen) or Ilaprazole 5 mg, amoxicillin 1 g, furazolidone 100 mg, tetracycline 750 mg (IAFT regimen)，all are used twice daily except tetracycline which is taken 3 times daily.
干预措施: amoxicillin and furazolidone or amoxicillin and tetracycline (Drug)
salvage therapy for failed eradication
If failed with AST guided eradication therapy, patients will take another therapy according to the former AST results. One susceptible antibiotics not involved in last therapy will be used as a component of 14-day bismuth-based quadruple regimen with Ilaprazole 5 mg b.i.d, amoxicillin 1 g b.i.d and Colloidal Bismuth Pectin 200 mg b.i.d.
干预措施: proton pump inhibitor (PPI) and Colloidal Bismuth Pectin (Drug)
salvage therapy for failed eradication
If failed with AST guided eradication therapy, patients will take another therapy according to the former AST results. One susceptible antibiotics not involved in last therapy will be used as a component of 14-day bismuth-based quadruple regimen with Ilaprazole 5 mg b.i.d, amoxicillin 1 g b.i.d and Colloidal Bismuth Pectin 200 mg b.i.d.
干预措施: amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin (Drug)
结局指标
主要结局
Eradication rates in 2 groups
时间窗: 6 months
次要结局
- the rate of improving dyspepsia symptoms after H. pylori eradication(6 months)
- the rate of adverse events happening(6 months)
- the rate of good compliance (take pills more than 90%)(5 months)
- difference of cost per patient for each eradication achieved in 2 groups(6 months)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University