Susceptibility-Guided Sequential Therapy Versus Empirical Therapy for Helicobacter Pylori Infection: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- the first-line H. pylori eradication rate
研究概览
简要总结
The main objective of this trial is to assess whether a sequential therapy strategy based on molecular antibiotic susceptibility testing (including clarithromycin and fluoroquinolone) for H. pylori infection will improve the eradication rate compared to an empirical therapy.
详细描述
This trial is designed as a prospective, randomised, open-label, active-controlled and single-centre study. For empirical therapy group(control group), Bismuth quadruple therapy will be an empirical first-line therapy, and high dose dual (proton-pump inhibitor + amoxicillin) treatment will be for rescue therapy if the first-line empirical treat failure. For the susceptibility-guided sequential therapy group, regimens were selected based on H. pylori susceptibility to clarithromycin and levofloxacin. The primary outcome is the first-line eradication rate in both groups, and the overall (including first- and rescue therapies) H. pylori eradication rates in both groups is one of the secondary outcomes. The eradication rates of H. pylori will be analysed by intention-to-treat analysis, modified intention-to-treat analysis and per-protocol analysis.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •H. pylori infection was determined using at least one of the following tests: 13C/14C-urea breath test (UBT), stool H. pylori antigen test, rapid urease test, and histological analysis within 4 weeks.
- •Patients were naïve to H. pylori treatment.
排除标准
- •Allergy to any drug administered.
- •Pregnancy and lactation.
- •Major systemic diseases, such as severe cardiopulmonary or liver dysfunction.
- •Complicated with active peptic ulcer disease, gastric cancer, or prior gastrectomy.
研究组 & 干预措施
clarithromycin-sensitive(first-line)
If H. pylori is sensitive to clarithromycin, we will administer clarithromycin triple therapy-esomeprazole (20 mg, twice daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily)-for 14 days
干预措施: clarithromycin-sensitive(first-line) (Drug)
clarithromycin-resistant(first-line)
If H. pylori is clarithromycin resistance, we selected the High-dose dual therapy (HDDT) regimen as first-line treatment. HDDT-esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily)-will be used for 14 days.
干预措施: clarithromycin-resistant(first-line) (Drug)
empirical therapy group first-line
The empirical therapy group will receive Bismuth-containing quadruple therapy(BQT) as first-line treatment, The BQT regime is comprising of esomeprazole (20 mg, twice daily), colloidal bismuth pectin (150 mg, four times daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days.
干预措施: empirical therapy group first-line (Drug)
levofloxacin-sensitive(rescue treatment)
If H. pylori was levofloxacin-sensitive, we will use the levofloxacin quadruple regimen as rescue treatment-esomeprazole (20 mg, twice daily), levofloxacin (500 mg, once daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily)-for 14 days.
干预措施: levofloxacin-sensitive(rescue treatment) (Drug)
levofloxacin-resistant(rescue treatment)
If H. pylori was levofloxacin-resistant, we will use furazolidone quadruple regimen as rescue treatment-esomeprazole (20 mg, twice daily), furazolidone (100 mg, twice daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily)-for 14 days.
干预措施: levofloxacin-resistant(rescue treatment) (Drug)
empirical therapy group rescue treatment
If BQT fails, HDDT-esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily)-will be used as a rescue treatment for 14 days.
干预措施: empirical therapy group rescue treatment (Drug)
结局指标
主要结局
the first-line H. pylori eradication rate
时间窗: 4-8 weeks after the end of treatment.
the proportion of participants with successful H. pylori eradication, as determined by 13C-Urea breath test(UBT), at least 4 weeks after the end of the first-line treatment period between Susceptibility-guided therapy(SGT) and empirical therapy(ET) group.
次要结局
- the overall H.pylori eradication rate(4-8 weeks after the second treatment)
- high-dose dual therapy eradication rate(4-8 weeks after the second treatment)
- the rescue H. pylori eradication rate(4-8 weeks after the second treatment)
- Adverse events and compliance(3 days after the end of treatment.)