Helicobacter Pylori Eradication Rates of Concomitant Therapy and Tailored Therapy Based on 23S Ribosomal RNA Point Mutations Associated With Clarithromycin Resistance: A Multicenter Prospective Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 423
- 试验地点
- 1
- 主要终点
- Comparison of success rate of H. pylori eradication between tailored therapy and concomitant therapy.
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and compliance of tailored therapy which using the polymerase chain reaction for point mutation of clarithromycin, compared to concomitant therapy, in patients without history of H. pylori eradication.
详细描述
Purpose of Study>
- To evaluate the efficacy of tailored therapy compared to concomitant therapy.
- Difference in eradication rate according to the frequency of 23S ribosomal RNA point mutation in clarithromycin.
- To evaluate the compliance of tailored therapy compared to concomitant.
- To analysis of factors which influence to the eradication rate.
Patients>
; Target disease
- peptic ulcers(gastric ulcer, duodenal ulcer),
- gastric MALToma,
- Endoscopic therapy state of early gastric cancer or gastric adenoma,
- Patients who require H. pylori testing by clinical judgment, such as chronic gastritis.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •H. pylori infection diagnosed patient, between 18 years old and 80 years old
- •No history of H. pylori eradication therapy
- •No antibiotic use for more than 3 days within 1 month of treatment
排除标准
- •History of taking antibiotics for more than 3 days in the last 1 month
- •History of subtotal or partial gastrectomy
- •Patients with other systemic disorders such as severe liver function, kidney function, cardiopulmonary function abnormality
- •Pregnant and lactating women
- •Disagree with the survey or do not respond to the questionnaire
- •Contraindications for each medications
研究组 & 干预措施
concomitant group
lansoprazole 30 mg tablet, amoxicillin 1.0 g tablet, metronidazole 500 mg tablet and clarithromycin 500 mg tablet by mouth every 12 hours for 2 weeks, regardless of 23S ribosomal RNA point mutation.
干预措施: Lansoprazole 30mg (Drug)
concomitant group
lansoprazole 30 mg tablet, amoxicillin 1.0 g tablet, metronidazole 500 mg tablet and clarithromycin 500 mg tablet by mouth every 12 hours for 2 weeks, regardless of 23S ribosomal RNA point mutation.
干预措施: Amoxicillin 1.0g Tab (Drug)
concomitant group
lansoprazole 30 mg tablet, amoxicillin 1.0 g tablet, metronidazole 500 mg tablet and clarithromycin 500 mg tablet by mouth every 12 hours for 2 weeks, regardless of 23S ribosomal RNA point mutation.
干预措施: Clarithromycin 500mg (Drug)
concomitant group
lansoprazole 30 mg tablet, amoxicillin 1.0 g tablet, metronidazole 500 mg tablet and clarithromycin 500 mg tablet by mouth every 12 hours for 2 weeks, regardless of 23S ribosomal RNA point mutation.
干预措施: Metronidazole 500 mg (Drug)
tailored treatment group I
23S ribosomal RNA point mutation negative, lansoprazole 30 mg, amoxicillin 1.0 g, and clarithromycin 500 mg were administered twice a day for 2 weeks.
干预措施: Lansoprazole 30mg (Drug)
tailored treatment group I
23S ribosomal RNA point mutation negative, lansoprazole 30 mg, amoxicillin 1.0 g, and clarithromycin 500 mg were administered twice a day for 2 weeks.
干预措施: Amoxicillin 1.0g Tab (Drug)
tailored treatment group I
23S ribosomal RNA point mutation negative, lansoprazole 30 mg, amoxicillin 1.0 g, and clarithromycin 500 mg were administered twice a day for 2 weeks.
干预措施: Clarithromycin 500mg (Drug)
tailored treatment group II
23S ribosomal RNA point mutation positive, lansoprazole 30 mg, amoxicillin 1.0 g and metronidazole 500 mg For 2 weeks.
干预措施: Lansoprazole 30mg (Drug)
tailored treatment group II
23S ribosomal RNA point mutation positive, lansoprazole 30 mg, amoxicillin 1.0 g and metronidazole 500 mg For 2 weeks.
干预措施: Clarithromycin 500mg (Drug)
tailored treatment group II
23S ribosomal RNA point mutation positive, lansoprazole 30 mg, amoxicillin 1.0 g and metronidazole 500 mg For 2 weeks.
干预措施: Metronidazole 500 mg (Drug)
结局指标
主要结局
Comparison of success rate of H. pylori eradication between tailored therapy and concomitant therapy.
时间窗: At 4 weeks after the completion of drug administration, the urea breath test is performed to check for eradication, Before the urea breath test, the proton pump inhibitor or H2 blocker should be discontinued for 2 weeks.
Comparison of percentage of people who succeeded in H. pylori eradication among all participants in each treatment group (tailored therapy vs concomitant therapy)
次要结局
- Difference in eradication rate according to the frequency of 23S ribosomal RNA point mutation in clarithromycin(Before the treatment, 23S ribosomal RNA point mutation is confirmed and at least 4 weeks after the end of treatment, urea breath test is performed to check whether or not eradication is completed.)
研究者
Kim Ji Hyun
Clinical Professor
Inje University