Bismuth Quadruple Therapy in Helicobacter Pylori Rescue Therapy: A Multicenter Randomized Non-Inferiority Trial of Different Tetracycline Doses and Frequencies.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Eradication rate
研究概览
简要总结
The researchers collect H.pylori-positive patients who need rescue therapy from the outpatient clinic. The subjects were randomized to receive a dose and frequency of tetracycline 500mg tid or qid of bismuth quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates and patient compliance of each group.
详细描述
The researchers collect H.pylori-positive patients who need rescue therapy from the outpatient clinic. If the subject meets the selection criteria but not the exclusion criteria, and signs an informed consent form, the researchers randomized the subjects in groups: subjects received a dose and frequency of tetracycline 500mg tid or qid of bismuth quadruple eradication therapy. The medication of groups are as follows. 6-8 weeks after the eradication treatment, the subjects will review the 13C-urea breath test, and the researcher records the results.
After all subjects were tested, the eradication rates, adverse reaction rates and patient compliance of each group were calculated.
According to the dose and frequency of tetracycline, it is randomized into a tid treatment group and a qid treatment group. The two groups of bismuth quadruple regimens are the same, as follows:
Tid group: Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 40mg bid
Qid group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 40mg bid
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-
- •Patients with H.pylori infection (Positive for rapid urease test or 13C/14C-urea breath test).
- •Patients who have previous failed H. pylori eradication treatment, and ≤ 2 times.
排除标准
- •Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 1.5 times 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 who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
- •Patients with active gastrointestinal bleeding.
- •Patients with a history of upper gastrointestinal surgery.
- •Patients allergic to treatment drugs.
- •Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks
- •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
Tid group
Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 40mg bid
干预措施: Tetracycline 500mg tid (Drug)
Qid group
Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 40mg bid
干预措施: Tetracycline 500mg qid (Drug)
结局指标
主要结局
Eradication rate
时间窗: through study completion, an average of 1.5 years
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 two 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(through study completion, an average of 1.5 years)
- Patient compliance(through study completion, an average of 1.5 years)
研究者
Yanqing Li
Clinical Professor
Shandong University