Efficacy and Safety of Bismuth Quadruple Therapy Containing Cefuroxime and Tetracycline as First-line Therapy for Eradicating Helicobacter Pylori in Patients Allergic to Penicillin: A Multicenter, Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Eradication rate
研究概览
简要总结
The researchers collected untreated H. pylori positive patients from outpatient clinics. Subjects were randomly assigned to receive either 14 days of bismuth quadruple therapy with cefuroxime and tetracycline or 14 days of bismuth quadruple therapy with cefuroxime and levofloxacin for Helicobacter pylori eradication. After 6 weeks of treatment, subjects underwent another 13C urea breath test. Eradication rates, adverse reaction rates and patient compliance were calculated.
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
- •Age 18-70 years old, regardless of gender.
- •History of penicillin allergy.
- •Helicobacter pylori infection.
- •Patients who have not previously received Helicobacter pylori eradication therapy.
排除标准
- •Medication history of bismuth and antibiotics within 4 weeks; PPIs and P-CABs within 2 weeks.
- •Serious underlying diseases, such as liver insufficiency, renal insufficiency, malignant tumors, etc.
- •Previous gastric or esophageal surgery.
- •History of allergy to test drugs.
- •Pregnant and lactating women and those unwilling to use contraception during the trial period.
- •Have other behaviors that may increase the risk such as alcohol and drug abuse.
- •Those unable to provide informed consent.
研究组 & 干预措施
14-day bismuth quadruple regimen containing cefuroxime and tetracycline
14-day bismuth quadruple regimen containing cefuroxime and tetracycline:Tegoprazan (50mg twice/day before breakfast and supper), Bismuth potassium citrate capsule (0.6g twice/day before breakfast and supper), Cefuroxime tablets (500mg twice/day after breakfast and supper), Tetracycline (500mg three times/day after three meals);14 days.
干预措施: 14-day bismuth quadruple regimen containing cefuroxime and tetracycline (Drug)
14-day bismuth quadruple regimen containing cefuroxime and levofloxacin
14-day bismuth quadruple regimen containing cefuroxime and levofloxacin:Tegoprazan (50mg twice/day before breakfast and supper), Bismuth potassium citrate capsule (0.6g twice/day before breakfast and supper), Cefuroxime tablets (500mg twice/day after breakfast and supper), Levofloxacin (500mg once/day after breakfast);14 days.
干预措施: 14-day bismuth quadruple regimen containing cefuroxime and levofloxacin (Drug)
结局指标
主要结局
Eradication rate
时间窗: immediately after the procedure
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.
次要结局
- Rate of adverse reactions(immediately after the procedure)
- Patient compliance(immediately after the procedure)