A Multi-center Study for Eradication of Helicobacter Pylori With Triple Therapy Based on Accurate Susceptibility Testing of Clarithromycin
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 672
- 试验地点
- 1
- 主要终点
- Establish individualized precision triple therapy based on minimal inhibitory concentration.
研究概览
简要总结
As the resistant rate of the Helicobacter pylori to some common antibiotics was rising，the eradication rate of the Helicobacter pylori with the standard triple therapy failed to exceed 70% in China，and had to drop out of the first-line treatment recommendations. However, with the increase of treatment time, patients burden, adverse reactions of antibiotics or proton pump inhibitor (PPI) will also increase. Resistance to clarithromycin is the major cause of the failure to eradicate Helicobacter pylori. But, in terms of population, there are still more than 70% of the patients with clarithromycin sensitive. Under the guidance with susceptibility test，7-day standard triple therapy could be used. In this study, investigators will select the patients with infection of H. pylori and with clarithromycin sensitive. Eradication of Helicobacter pylori with triple therapy based on accurate susceptibility testing of clarithromycin will be studied. The treatment time will be assigned into 7 days,10 days and 14 days groups. Then, investigators will perform a sequencing for failed treatment patients in groups, such as drug resistance gene mutation, phenotype and genotype. Finally, investigators will compare the differences between the patients with triple therapy and traditional quadruple therapy.The incidence of adverse effects in the eradicate treatment will reduce at least 10% and avoid patients' unnecessary economic losses at least 400RMB per person.
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, male or female, the first eradication therapy of H. pylori infection patients.
- •Symptoms of abdominal pain, bloating, acid efflux, belching, nausea, vomiting, heartburn, chest pain, vomiting, melena, etc.
- •Unused antibiotics, bismuth, H2 receptor antagonists or PPI by nearly 4 weeks
- •13C-labelled urea breath test positive.
- •Agreed to Helicobacter pylori culture and sensitivity testing taken by endoscopy gastric biopsy specimens,and the result of culture was positive.
- •Agreed to Helicobacter pylori eradication therapy and cooperate with the eradication efficacy follow-up survey.
排除标准
- •Severe heart, liver, kidney dysfunction.
- •Pregnant or lactating women.
- •Complications of bleeding, perforation, pyloric obstruction, cancer.
- •Within 3 months before with the drugs involved in other drugs research.
- •Esophageal,gastrointestinal surgery history.
- •Patients can not properly express their complaints,such as psychosis, severe neurosis.
- •Taking NSIAD or alcohol abusers.
- •Allergic to amoxicillin or clarithromycin tested by susceptibility testing.
研究组 & 干预措施
Clarithromycin resistance group
Patients who are resistant to clarithromycin in susceptibility test were classified into clarithromycin resistance group.
干预措施: The results of clarithromycin susceptibility test of H. pylori isolates (Device)
7 days Successful treatment
The successful treatment of H. pylori group were treatment successful patients after the 7days standardized treatment.
干预措施: The results of clarithromycin susceptibility test of H. pylori isolates (Device)
7 days Successful treatment
The successful treatment of H. pylori group were treatment successful patients after the 7days standardized treatment.
干预措施: Computer generated random number, randomly assigned into groups (Device)
7 days Successful treatment
The successful treatment of H. pylori group were treatment successful patients after the 7days standardized treatment.
干预措施: The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups (Device)
7 days failed treatment
The failed treatment of H. pylori group were treatment failure patients after the 7days standardized treatment.
干预措施: The results of clarithromycin susceptibility test of H. pylori isolates (Device)
7 days failed treatment
The failed treatment of H. pylori group were treatment failure patients after the 7days standardized treatment.
干预措施: Computer generated random number, randomly assigned into groups (Device)
7 days failed treatment
The failed treatment of H. pylori group were treatment failure patients after the 7days standardized treatment.
干预措施: The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups (Device)
14 days failed treatment
The failed treatment of H. pylori group were treatment failure patients after the 14days standardized treatment.
干预措施: Computer generated random number, randomly assigned into groups (Device)
14 days failed treatment
The failed treatment of H. pylori group were treatment failure patients after the 14days standardized treatment.
干预措施: The results of clarithromycin susceptibility test of H. pylori isolates (Device)
10 days Successful treatment
The successful treatment of H. pylori group were treatment successful patients after the 10days standardized treatment.
干预措施: The results of clarithromycin susceptibility test of H. pylori isolates (Device)
10 days Successful treatment
The successful treatment of H. pylori group were treatment successful patients after the 10days standardized treatment.
干预措施: Computer generated random number, randomly assigned into groups (Device)
10 days Successful treatment
The successful treatment of H. pylori group were treatment successful patients after the 10days standardized treatment.
干预措施: The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups (Device)
10 days failed treatment
The failed treatment of H. pylori group were treatment failure patients after the 10days standardized treatment.
干预措施: The results of clarithromycin susceptibility test of H. pylori isolates (Device)
10 days failed treatment
The failed treatment of H. pylori group were treatment failure patients after the 10days standardized treatment.
干预措施: Computer generated random number, randomly assigned into groups (Device)
10 days failed treatment
The failed treatment of H. pylori group were treatment failure patients after the 10days standardized treatment.
干预措施: The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups (Device)
14 days Successful treatment
The successful treatment of H. pylori group were treatment successful patients after the 14days standardized treatment.
干预措施: The results of clarithromycin susceptibility test of H. pylori isolates (Device)
14 days Successful treatment
The successful treatment of H. pylori group were treatment successful patients after the 14days standardized treatment.
干预措施: Computer generated random number, randomly assigned into groups (Device)
14 days Successful treatment
The successful treatment of H. pylori group were treatment successful patients after the 14days standardized treatment.
干预措施: The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups (Device)
14 days failed treatment
The failed treatment of H. pylori group were treatment failure patients after the 14days standardized treatment.
干预措施: The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups (Device)
结局指标
主要结局
Establish individualized precision triple therapy based on minimal inhibitory concentration.
时间窗: 2.5 years
Based on the clarithromycin accurate susceptibility，pinpoint different courses of triple treatment therapy targeted to different people based on minimal inhibitory concentration of clarithromycin.
The accurate determination of clarithromycin susceptibility.
时间窗: 2 years
Assess bacterial susceptibility to antibiotics using the agar diffusion method. The Resistance point of clarithromycin was divided into 0.125μg/ml,0.25μg/ml,0.5μg/ml and 1μg/ml.Test clarithromycin resistance of Helicobacter pylori for patients.
次要结局
- The incidence of adverse effects(3 years)
研究者
Hongzhang Li
Director of Sanmen People's Hospital
Sanmen People's Hospital