Medico-economic Evaluation of a Therapeutic Strategy Based on Molecular Detection of Antibiotic Resistance in the Management of H Pylori Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,386
- 试验地点
- 1
- 主要终点
- H. pylori eradication rate (at 3months according to the two strategies: empirical treatment versus treatment guided by molecular detection of antibiotic resistance)
研究概览
简要总结
H pylori eradication failure with recommended triple therapy is mainly related to antibiotic resistance. However,IN VITRO culture of H pylori is uneasy and is not performed in routine practice. A molecular test of antibiotic resistance easy to perform is now available. The aim of the study was to compare eradication rates obtained with the standard treatment and with a treatment guided by the results of the molecular detection of antibiotic resistance.
详细描述
At the present time, H pylori infection is treated with a standard triple therapy. Treatment of naïve patients with triple therapy ( PPI+amoxicillin+clarithromycin for 7 days) markedly decreased last years to reach 70% due to a clarithromycin resistance rate about 20% in France. In case of failure, the recommended second line treatment (PPI+amoxicillin+metronidazole for 14 days) gives a success rate of 60%. However, as culture is uneasy and is only possible in specialised labs sensitivity to antibiotics is not currently studied before treatment.
The aim of the study was to evaluate clinical and medico-economic benefit of the molecular detection of antibiotic resistance in order to guide the treatment.
The test is performed after DNA extraction from biopsy specimens taken at gastroscopy allowing rapid detection of H pylori and clarithromycin or quinolone resistance.
Patients with bacteriologically proven H pylori infection will be randomly allocated to either empirical usual treatment with PPI , amoxicillin 1g, clarithromycin 500 mg X 2 /day for 7 days in naïve patients and PPI, amoxicillin 1g,metronidazole 500 mg X 2 /day for 14 days in patients who failed a first line treatment , or to treatment guided by the molecular test: PPI , amoxicillin 1g, clarithromycin 500 mg X 2 /day for 7 days in case of sensitivity to clarithromycin.In case of resistance to clarithromycin, quinolone should be given and in case of resistance to quinolone clarithromycin should be given. In case of resistance to both antibiotics metronidazole should be given.
Eradication will be assessed by performing 4 weeks after the completion of treatment with Urea Breath Test.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •H pylori infection bacteriologically confirmed
- •Age > 18 years
- •Naïve patient or one failure of the first line recommended treatment
- •Patient referred to one out of the centres participating in the study
排除标准
- •H pylori positive patient with at least failure of two lies of treatment
- •patients with previous adverse event with PPI, amoxicillin, clarithromycin, levofloxacin or metronidazole
- •PPI or antibiotic treatment in progressor stopped for less than 4 weeks
- •patient with other severe sickness
研究组 & 干预措施
Helicobacter pilory triple treatment
Triple treatment on this arm is based on results of molecular detection of resistance to antibiotics
干预措施: Molecular detection of antibiotic resistance (Drug)
Helicobacter pilori standard recommended treatment
H.Pylori Eradication rate with empirical treatment
干预措施: standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole) (Drug)
结局指标
主要结局
H. pylori eradication rate (at 3months according to the two strategies: empirical treatment versus treatment guided by molecular detection of antibiotic resistance)
时间窗: at 3 months
at 3 months according to the two strategies: empirical treatment versus treatment guided by molecular detection of antibiotic resistance
次要结局
- Comparative cost of the two strategies(at 6 months according to the two strategies)