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Completed

NCT Number: NCT02274922

Evaluation of Immunochromatographic Tests for Campylobacter Detection in Stools

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. positive Campylobacter detection with ICT

    Time frame: The day of inclusion

Secondary outcomes

  1. result of PCR

    Time frame: The day of inclusion

  2. result of PCR

    Time frame: 15 days after inclusion

  3. stool culture

    Time frame: The day of inclusion

  4. stool culture

    Time frame: 15 days after inclusion

  5. ELISA

    Time frame: The day of inclusion

  6. ELISA

    Time frame: 15 days after inclusion

  7. serology for Campylobacter detection

    Time frame: The day of inclusion

  8. serology for Campylobacter detection

    Time frame: 15 days after inclusion

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: CAMPYTEST

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 24, 2014
Registry last updated
Aug 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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