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临床试验/NCT02274922
NCT02274922已完成不适用

Evaluation of Immunochromatographic Tests for Campylobacter Detection in Stools

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 308 人开始时间: 2014年4月最近更新:
适应症

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

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)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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