Evaluation of Immunochromatographic Tests for Campylobacter Detection in Stools

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Immunochromatographic Tests for Campylobacter Detection in Stools

Conditions
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Gastroenteritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: there is no  non-inclusion  criteria
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive Campylobacter detection with ICT |  | The day of inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| result of PCR |  | The day of inclusion | 
| result of PCR |  | 15 days after inclusion | 
| stool culture |  | The day of inclusion | 
| stool culture |  | 15 days after inclusion | 
| ELISA |  | The day of inclusion | 
| ELISA |  | 15 days after inclusion | 
| serology for Campylobacter detection |  | The day of inclusion | 
| serology for Campylobacter detection |  | 15 days after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Campylobacter diagnosis,, immuno-chromatographic test, ELISA, PCR, culture, stool, ELISA,, PCR,, culture, stool