Sequential Helicobacter Pylori Eradication Therapy in Myanmar; a Randomized Clinical Trial of Efficacy and Tolerability
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 313
- 试验地点
- 1
- 主要终点
- Efficacy of sequential Helicobacter Pylori Eradication Therapy versus concomitant Helicobacter Pylori Eradication Therapy.
研究概览
简要总结
This study aims to:
- Determine the prevalence of Helicobacter infection in Myanmar (this would be the largest ever series in the country)
- Determine the clinical and epidemiological associations of Helicobacter infection in Myanmar
- Determine the utility of stool antigen testing to diagnose the infection and confirm eradication
- Compare the relative efficacies of concomitant and sequential therapy
- Determine the relative efficacies of first, second and third line therapies in Myanmar in 2018
详细描述
There are very few published studies to examine the prevalence of Helicobacter infection in Myanmar. Two previous studies (both < 400 participants) suggested that the prevalence was approximately 50% (Myint WJG 2015, Aye MMJ 2015).
The high prevalence of H.pylori is important because gastric adenocarcinoma is the fourth most common cancer in the country (WHO 2014). Gastric cancer has an almost uniformly dismal 5-year survival rates in this resource-limited country and is estimated to kill almost 5000 patients per year in Myanmar (WHO 2014).
In addition, anecdotally there is a significant associated burden of peptic ulcer disease in the country, although there are few published data to examine the issue.
Strategies to diagnose and eradicate H.pylori must be considered in the context that the annual per capita health budget is USD103 (World Bank 2016).
Therapeutic regimens must also consider the issue of antimicrobial resistance, which varies from country to country. There are very few data from Myanmar to guide us and those that are available vary enormously.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Satisfies one of the criteria for H. pylori testing in the 2017 American College of Gastroenterology guidelines
- •Informed consent
排除标准
- •No informed consent
研究组 & 干预措施
Sequential therapy
Sequential Clarithromycin + Amoxycillin + Tinidazole + rabeprazole by mouth (Both amoxycillin 1000mg every 12 hours and rabeprazole 20 mg every 12 hours for 5 days, followed by clarithromycin 500 mg every 12 hours, tinidazole 500mg every 12 hours and rabeprazole 20 mg every 12 hours for 5 days)
干预措施: Tinidazole 500mg (Drug)
Sequential therapy
Sequential Clarithromycin + Amoxycillin + Tinidazole + rabeprazole by mouth (Both amoxycillin 1000mg every 12 hours and rabeprazole 20 mg every 12 hours for 5 days, followed by clarithromycin 500 mg every 12 hours, tinidazole 500mg every 12 hours and rabeprazole 20 mg every 12 hours for 5 days)
干预措施: Clarithromycin 500mg (Drug)
Sequential therapy
Sequential Clarithromycin + Amoxycillin + Tinidazole + rabeprazole by mouth (Both amoxycillin 1000mg every 12 hours and rabeprazole 20 mg every 12 hours for 5 days, followed by clarithromycin 500 mg every 12 hours, tinidazole 500mg every 12 hours and rabeprazole 20 mg every 12 hours for 5 days)
干预措施: Amoxicillin 500mg (Drug)
Sequential therapy
Sequential Clarithromycin + Amoxycillin + Tinidazole + rabeprazole by mouth (Both amoxycillin 1000mg every 12 hours and rabeprazole 20 mg every 12 hours for 5 days, followed by clarithromycin 500 mg every 12 hours, tinidazole 500mg every 12 hours and rabeprazole 20 mg every 12 hours for 5 days)
干预措施: Rabeprazole 20mg (Drug)
Concomitant therapy
Concomitant clarithromycin 500mg every 12 hours + amoxycillin 1000mg every 12 hours + tinidazole 500mg every 12 hours + rabeprazole 20mg every 12 hours (all drugs by mouth for 14 days).
干预措施: Clarithromycin 500mg (Drug)
Concomitant therapy
Concomitant clarithromycin 500mg every 12 hours + amoxycillin 1000mg every 12 hours + tinidazole 500mg every 12 hours + rabeprazole 20mg every 12 hours (all drugs by mouth for 14 days).
干预措施: Amoxicillin 500mg (Drug)
Concomitant therapy
Concomitant clarithromycin 500mg every 12 hours + amoxycillin 1000mg every 12 hours + tinidazole 500mg every 12 hours + rabeprazole 20mg every 12 hours (all drugs by mouth for 14 days).
干预措施: Tinidazole 500mg (Drug)
Concomitant therapy
Concomitant clarithromycin 500mg every 12 hours + amoxycillin 1000mg every 12 hours + tinidazole 500mg every 12 hours + rabeprazole 20mg every 12 hours (all drugs by mouth for 14 days).
干预措施: Rabeprazole 20mg (Drug)
结局指标
主要结局
Efficacy of sequential Helicobacter Pylori Eradication Therapy versus concomitant Helicobacter Pylori Eradication Therapy.
时间窗: 4 weeks after completion of initial eradication therapy, at an average of 6 weeks after randomization.
The proportion of participants with a negative stool antigen test 4 weeks after end of treatment in those who received Sequential Helicobacter Pylori Eradication Therapy compared with those who received concomitant Helicobacter Pylori Eradication Therapy.
次要结局
- The number of participants with adverse drug reactions(During therapy with the agents and follow up for the 4 weeks after completion of antibiotic therapy; a total of 6 weeks.)
- Adherence to therapy(14 days)