Prospective Randomised Trial of First and Second Line Treatments of Helicobacter Pylori Infection in Slovenia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 560
- 试验地点
- 3
- 主要终点
- Success rate of first line therapy for Helicobacter pylori infection
研究概览
简要总结
Study is prospective randomised multicentric. The primary objective of the study is to compare the efficacy of two first-line therapy regimens and two second-line therapy regimens (ie, after failure of first-line treatment) in patients with H. pylori infection. The secondary objective of the study is to determine the primary resistance of H. pylori to antibiotics in Slovenia.
详细描述
The infection with Helicobacter pylori is extremely widespread, as 60% of the world's population is infected. In Slovenia, the average prevalence is 25.1 %, the prevalence in the 20-year age group is 20 % and 76 % in patients in age group 50 - 75 years. All infected patients have active chronic gastritis, which is asymptomatic in most cases. Ulcers in the stomach or duodenum occurs in 15 % of patients. Due to chronic infection, MALT lymphoma or gastric cancer develop in 1 - 3 % of patients. According to the recommendations of the Slovenian Association for Gastroenterology and Hepatology, as well as European and other recommendations, everyone who is infected with Helicobacter pylori should be treated. H. pylori is a first-class carcinogen and is responsible for 50 % of all chronic cancer-causing infections in the developed world. Therefore, it is necessary to start programs of primary and secondary prevention of gastric cancer by searching and treating infected patients.
Patients infected with H. pylori who have not yet been treated will be randomly assigned to two first-line treatment groups:
Group 1: Esomeprazole 40 mg, Clarithromycin 500 mg, Amoxicillin 1000 mg, all BID,14 days Group 2: Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg, all QID Esomeprazole 40 mg BID, 14 days
Patients unsuccessfully treated with first-line therapy will be randomly assigned to two second-line treatment groups:
Group 1: Esomeprazole 40 mg BID, Levofloxacin 500 mg OID, Amoxicillin 1000 mg BID, 14 days Group 2: Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg, all QID, Esomeprazole 40 mg BID, 14 days
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Prior treatment for Helicobacter pylori infection (in patients who will receive Schedule 1 eradication therapy).•
- •Defects in blood clotting. taking anticoagulant medicines that make it impossible to take biopsies.
- •Allergy to drugs used in the study.
- •Pregnancy, breastfeeding shold be excluded.
- •Psychiatric illness that would prevent research participation.
- •Active treatment for malignancy.
研究组 & 干预措施
First line therapy for H pylori infection
Tripple 14 day first line therapy Esomeprazole 40 mg, Clarithromycin 500 mg, Amoxicillin 1000 mg, all BID 14 days
干预措施: Esomeprazole 40mg, Clarithromycin 500 mg, Metronidazole 400 mg, (Drug)
First line therapy for H pylori infection second arm
Bismuth quadruple first line therapy
Bismuth subcitrat 120 mg , Amoxicillin 500 mg, Metronidazole 400 mg, all QID, Esomeprazole 40 mg BID, 14 days.
干预措施: Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg (Drug)
Second line therapy for H pylori infection
Bismuth quadruple second line therapy for those treated with Tripple first line therapy
Bismuth subcitrat 120 mg , Amoxicillin 500 mg, Metronidazole 400 mg, all QID, Esomeprazole 40 mg BID, 14 days.
干预措施: Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg (Drug)
Second line therapy for H pylori infection second arm
Tripple second line therapy
Esomeprazol 40 mg BID Amoxicillin 1000 mg BID, Levofloxacin 500 mg OID, 14 days or
干预措施: Esomeprazole 40mg, Amoxicillin 500 mg, Levofloxacin 500 mg (Drug)
结局指标
主要结局
Success rate of first line therapy for Helicobacter pylori infection
时间窗: 2 years
Eradication rate
Success rate of second line therapy for Helicobacter pylori infection
时间窗: 3 years
Eradication rate
次要结局
- Helicobacter pylori resistance rate to antibiotics(3 years)