NCT03566004已完成不适用
Performance of a Non-invasive Test for the Detection of Helicobacter Pylori and Its Resistance to Clarithromycin in Stool by Real-Time PCR Amplidiag H. Pylori + ClariR (Mobidiag)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Detection of H. pylori by culture or glmM real-time PCR
研究概览
简要总结
Performance of a non-invasive test for the detection of Helicobacter pylori and its resistance to clarithromycin in stool by Real-Time PCR Amplidiag H. pylori + ClariR (Mobidiag).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •indication of endoscopy with biopsies for H. pylori infection
- •Free subject, without tutorship or curatorship or subordination
- •Patients benefiting from a social security scheme or benefiting through a third party
- •Consent informed and signed by the patient after clear and fair information about the study
排除标准
- •Age <18 years
- •Contraindications to fibroscopy (suspicion of oesophageal perforation)
- •Antibiotic intake less than 4 weeks old
- •Diarrheal patients during sampling
- •Patients who do not benefit from a social security scheme or who do not benefit from it through a third party
- •Persons enjoying enhanced protection, namely minors, pregnant women, breastfeeding, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergency situation.
- •Pregnant or lactating women, women of childbearing potential who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy )
结局指标
主要结局
Detection of H. pylori by culture or glmM real-time PCR
时间窗: Day30
Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies.
时间窗: Day 30
次要结局
未报告次要终点
研究者
研究点 (1)
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