Evaluation of Immunochromatographic Tests for Campylobacter Detection in Stools

Completed

• Conditions: Gastroenteritis

• Registration Number: NCT02274922
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-10-22
• Study First Submitted QC: 2014-10-23
• Study First Posted: 2014-10-24
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-25
• Last Update Posted: 2017-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 308

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
positive Campylobacter detection with ICT	The day of inclusion

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France