Comparison Between Ten Days Sequential Treatment (With Metronidazole or Tetracycline) and Ten Days Standard Triple Therapy of Helicobacter Pylori
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 345
- 试验地点
- 1
- 主要终点
- Eradication rate
研究概览
简要总结
The purpose of this study is to compare the eradication efficacy of 10-day triple therapy with 10-day sequential therapy with tetracycline or metronidazole.
详细描述
Background: Antimicrobial resistance has decreased eradication rates for Helicobacter pylori infection worldwide.
Objective
To determine whether sequential treatment eradicates H. pylori infection better than standard triple-drug therapy for adults with dyspepsia or peptic ulcers in Taiwanese people.
Design: Randomized, single-blind, prospective controlled trial. Setting: A large tertiary referral hospital in eastern Taiwan. Patients: 450 patients with dyspepsia or peptic ulcers and infected by H. pylori.
Measurements: 13C-urea breath test, upper endoscopy, histologic evaluation, rapid urease test, bacterial culture, assessment of antibiotic resistance and CYP2C19 genotype of host.
Intervention: 450 patients with H. pylori infection are randomly assigned to receive one of the following therapeutic schemes: group A (5RA5RCT): rabeprazole (20 mg bid) plus amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus clarithromycin (500 mg bid) and tetracycline (1g bid) for a further 5 days; group B (5RA5RCM): rabeprazole (20 mg bid) plus amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus clarithromycin (500 mg bid) and metronidazole (500mg bid) for a further 5 days; group C as control: rabeprazole (20 mg bid) plus amoxicillin (1 g bid) and clarithromycin (500 mg bid.) for 10 days.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient proved with infection of H. pylori in gastric mucosa
- •adult with signed inform consent
排除标准
- •woman in breast feeding or pregnancy.
- •allergy to drugs used in study.
- •three months without use of any antibiotic agents.
- •patients under 20 years old.
研究组 & 干预措施
Seq-Metronidazole
10-day sequential therapy with metronidazole
干预措施: 5RA-5RCM (Drug)
Seq-Tetracycline
10-day sequential therapy with tetracycline.
干预措施: 5RA-5RCT (Drug)
Control
10-day standard triple therapy.
干预措施: 10RCA (Drug)
结局指标
主要结局
Eradication rate
时间窗: 4 weeks after complete use of drug for treatment
A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment
次要结局
未报告次要终点
研究者
Ming-Cheh Chen
Principal Investigator
Buddhist Tzu Chi General Hospital