NCT01486082Unknown不适用
Usefulness of Antimicrobial Susceptibility in the Eradication of Helicobacter Pylori
Hospital Donostia1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2011年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of patients in whom Helicobacter pylori was eradicated.
研究概览
简要总结
Due to the high rate of resistance to clarithromycin in our area the investigators proposed an study to assess the need of antibiogram previous to the empirical OCA 10 treatment, in order to improve the rate of eradication.
详细描述
Usefulness of antimicrobial susceptibility in the eradication of Helicobacter pylori
PURPOSE
Background:
- The rate of eradication of Helicobacter pylori with standard triple therapy (OCA: omeprazole + clarithromycin + amoxicillin) in our area is less than the expected according to the III Maastricht III consensus. However, the current guidelines recommend the use of this therapy.
- According to the Maastricht III consensus, in populations with high rates of clarithromycin resistance (15-20%) another therapy should be considered, or alternatively, testing antimicrobial susceptibility of the H. pylori prior to treatment.
Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of H. pylori infection provided by culture, histology or UBT.
- •Patients need and indication to treat (peptic ulcer disease, firs-degree family history of gastric cancer, MALT lymphoma or dyspeptic symptoms)
- •Patients must be 18 years or older.
- •Exclusion criteria:
- •Previous treatment for H. pylori eradication.
- •Patients who have severe concomitant disease.
- •Patients who have previous gastric surgery.
- •Patients who have intolerance to any antimicrobial drugs.
排除标准
- 未提供
结局指标
主要结局
Number of patients in whom Helicobacter pylori was eradicated.
时间窗: 9 months
The investigators will measure the rate of eradication in each gruop after OCA treatment. One group receive OCA without antibiogram and the other one after checking the sensitivity to clarithromycin.
次要结局
- Number of patient with adverse event(9 months)
- Cost of the eradication of Helicobacter Pylori in each group.(9 months)
研究者
LUIS BUJANDA
Director, Head of Gastroenterology Department, principal investigator, clinical proffesor
Hospital Donostia
研究点 (1)
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