Triple Versus Quadruple Therapy with Amoxicillin and Tetracycline for the Eradication of Helicobacter Pylori: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Eradication rate
研究概览
简要总结
The study aimed to compare the efficacy and safety of 7-day and 14-day vonoprazan-amoxicillin-tetracycline triple therapy with 14-day vonoprazan-amoxicillin-tetracycline-bismuth quadruple therapy for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.
详细描述
H. pylori-positive patients without eradication history were recruited according to inclusion and exclusion criteria and randomized to the intervention:
14-day quadruple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days 14-day triple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid 14 days 7-day triple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid 7 days Subjects were asked to record adverse events and 6 weeks after treatment, 13C-urea breath test was tested for confirmation. The eradication rates, adverse reaction rates and patient adherence were calculated and analysed, and the results were analysed to provide more information for eradication regimens of H. pylori.
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
- •Patients aged 18-70 years old;
- •Patients with H.pylori infection (positive rapid urease test, 13C/14C-urea breath test);
- •Patients without previous treatment for H. pylori eradication.
排除标准
- •Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate <50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%;
- •Patients with active gastrointestinal bleeding;
- •Patients with a history of upper gastrointestinal surgery;
- •Patients allergic to treatment drugs;
- •Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitor within 2 weeks;
- •Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial;
- •Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse;
- •Patients who are unwilling or incapable to provide informed consents.
研究组 & 干预措施
14-day quadruple regimen
Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days
干预措施: Vonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 days (Drug)
14-day triple regimen
Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 14 days
干预措施: Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 days (Drug)
7-day triple regimen
Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 7 days
干预措施: Vonoprazan-Amoxicillin-Tetracycline triple regimen for 7 days (Drug)
结局指标
主要结局
Eradication rate
时间窗: Immediately after follow-up check
13C-urea breath test was used to determine whether eradication was successful. Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in the three groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
次要结局
- Rate of adverse reactions(Immediately after follow-up check)
- Patient compliance(Immediately after follow-up check)
研究者
Yanqing Li
Principal Investigator
Shandong University