Evaluation of Immunochromatographic Tests for Campylobacter Detection in Stools
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- positive Campylobacter detection with ICT
研究概览
简要总结
For a long time, culture was the only way to detect Campylobacter. It appears that rapid immunochromatographic tests (ICT) have detected more positive cases compared to culture, ELISA and molecular tests. The aim of our study is to evaluate the specificity of the ICT which are really interesting tools to use since they allow a diagnosis in about 15 min, in comparison to different methods of detection even serology.
详细描述
All of the patients coming to an emergency care unit and for whom a stool culture is prescribed will be included, corresponding to an estimate number of 1,000 patients for two years. Every stools will be tested for Campylobacter using two different ICT tests in addition to the standard culture. Then, in function of the ICT test result : 1) in case of negative result, no other Campylobacter detection will be performed except the standard culture, 2) in case of positive result, stools will be tested for Campylobacter by two ELISA tests, one PCR and a serology at two different times (D0 and D15) will be performed. Around 70 patients should be detected positive with ICTs, according to precedent studies. The 70 patients detected positive with at least one of the two ICT will have a serology control 15 days after the ICT test. The reference test will be the combination of culture result, evolution of the serology between D0 and D15 and the PCR and ELISA results. We want to define a procedure to follow in order to detect as soon as possible and with the best results, the Campylobacters in the stool of patients. This has the aim of being able to manage patients who need appropriate antibiotic treatment, and also to reduce the time of hospitalization of patients quickly detected as suffering from a Campylobacter infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient of any age (pediatric and adult) and any sex
- •Admitted to the emergency hospital for less than 48 who had a stool sample for stool culture including women and elderly patients over 65 years
排除标准
- •there is no " non-inclusion " criteria
结局指标
主要结局
positive Campylobacter detection with ICT
时间窗: The day of inclusion
次要结局
- ELISA(15 days after inclusion)
- stool culture(15 days after inclusion)
- result of PCR(15 days after inclusion)
- serology for Campylobacter detection(15 days after inclusion)
