Clinical trial NCT02274922: Evaluation of Immunochromatographic Tests for Campylobacter Detection in Stools
Official title: Evaluation of Immunochromatographic Tests for Campylobacter Detection in Stools
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroenteritis
Keywords: Campylobacter diagnosis,
immuno-chromatographic test, ELISA, PCR, culture, stool
ELISA,
PCR,
culture, stool
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2014-10-24
Enrollment: 308
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: positive Campylobacter detection with ICT
timeFrame: The day of inclusion
Secondary outcomes:
measure: result of PCR
timeFrame: The day of inclusion
measure: result of PCR
timeFrame: 15 days after inclusion
measure: stool culture
timeFrame: The day of inclusion
measure: stool culture
timeFrame: 15 days after inclusion
measure: ELISA
timeFrame: The day of inclusion
measure: ELISA
timeFrame: 15 days after inclusion
measure: serology for Campylobacter detection
timeFrame: The day of inclusion
measure: serology for Campylobacter detection
timeFrame: 15 days after inclusion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique du CHU de Bordeaux
name: Perez Paul, MD
role: STUDY_CHAIR
References: