Five Days Quadruple and Clarithromycin Containing Triple Therapy as Empirical First and Second-Line Treatment for Helicobacter Pylori Eradication: a Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- H pylori eradication
研究概览
简要总结
The aim of this randomized trial is to compare the efficacy and tolerability of H. pylori eradication with a 5-day quadruple therapy versus a clarithromycin-containing triple therapy.
详细描述
Eligible patients with H pylori infection were randomized to receive either five-day QUAD (esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d.) or EAC (esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d.). H. pylori status was rechecked by 13C urea breath test 8 weeks after treatment. Patients who failed their respective therapy were invited to undergo H. pylori susceptibility testing and crossover to receive the alternative regimen for the same duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with H. pylori infection
- •did not receive H. pylori eradication therapy before
排除标准
- •patients who have received previous H. pylori eradication therapy
- •co-morbidity of liver cirrhosis
- •co-morbidity of renal failure
- •co-morbidity of alcoholism
- •co-morbidity of malignancy
- •received antibiotics, bismuth preparations, proton pump inhibitors or probiotic in the preceding three months
- •patients with known allergy to the medications used
- •patients with a history of previous gastrointestinal diseases or gastric surgery
- •pregnancy
研究组 & 干预措施
Quadruple therapy
First line: 5 days esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d.
Cross over second line for those who failed first line: 7 days esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d
干预措施: Quadruple therapy (Drug)
Triple Therapy
First line: 7 days esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d Second line cross over if failed first line: 7 days quadruple therapy: esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d.)
干预措施: Triple therapy (Drug)
结局指标
主要结局
H pylori eradication
时间窗: 8 weeks after treatment
Successful H pylori eradication documented by urea breath test after first and second line treatments. Cross over if patients failed first line treatment
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(10 weeks outpatient follow-up)
研究者
Dr Ivan FN Hung
Clinical Associate Professor
The University of Hong Kong