Evaluation of Immunochromatographic Tests for Campylobacter Detection in Stools

Gastroenteritis Clinical Trial

— CAMPYTEST  

Official title:

Evaluation of Immunochromatographic Tests for Campylobacter Detection in Stools

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274922
• Other study ID #: CHUBX 2013/05
• Status: Completed
• Phase: N/A
• First received: October 22, 2014
• Last updated: August 25, 2017
• Start date: April 2014
• Est. completion date: December 2015

Study information

• Verified date: August 2017
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroenteritis

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive Campylobacter detection with ICT		The day of inclusion
Secondary	result of PCR		The day of inclusion
Secondary	result of PCR		15 days after inclusion
Secondary	stool culture		The day of inclusion
Secondary	stool culture		15 days after inclusion
Secondary	ELISA		The day of inclusion
Secondary	ELISA		15 days after inclusion
Secondary	serology for Campylobacter detection		The day of inclusion
Secondary	serology for Campylobacter detection		15 days after inclusion