GastroenteritisCAMPYTESTNCT02274922
Evaluation of Immunochromatographic Tests for Campylobacter Detection in Stools
An observational study of Gastroenteritis, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastroenteritis
- How many people
- 308 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- there is no " non-inclusion " criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Gastroenteritis
- Keywords
- Campylobacter diagnosis,, immuno-chromatographic test, ELISA, PCR, culture, stool, ELISA,, PCR,, culture, stool
- Medical subject headings
- Gastroenteritis, Pathologic Complete Response
What is being measured
The primary outcome is the main question the study is designed to answer.
positive Campylobacter detection with ICT
Measured: The day of inclusion
Secondary outcomes (8)
result of PCR
Measured: The day of inclusion
result of PCR
Measured: 15 days after inclusion
stool culture
Measured: The day of inclusion
stool culture
Measured: 15 days after inclusion
ELISA
Measured: The day of inclusion
ELISA
Measured: 15 days after inclusion
serology for Campylobacter detection
Measured: The day of inclusion
serology for Campylobacter detection
Measured: 15 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroenteritisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Perez Paul, MD, Study chair, Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique du CHU de Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274922
- Sponsor's protocol ID
- CHUBX 2013/05
- Acronym
- CAMPYTEST
- Status last verified
- Aug 2017
- First submitted
- 22 Oct 2014
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunochromatographic Tests for Campylobacter Detection in Stools
- ClinicalTrials.gov ID
- NCT02274922
- Acronym / sponsor ID
- CAMPYTEST / CHUBX 2013/05
- Conditions
- Gastroenteritis
- Keywords
- Campylobacter diagnosis,, immuno-chromatographic test, ELISA, PCR, culture, stool, ELISA,, PCR,, culture, stool
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- there is no " non-inclusion " criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
positive Campylobacter detection with ICT
Time frame: The day of inclusion
8 secondary outcomes
result of PCR
Time frame: The day of inclusion
result of PCR
Time frame: 15 days after inclusion
stool culture
Time frame: The day of inclusion
stool culture
Time frame: 15 days after inclusion
ELISA
Time frame: The day of inclusion
ELISA
Time frame: 15 days after inclusion
serology for Campylobacter detection
Time frame: The day of inclusion
serology for Campylobacter detection
Time frame: 15 days after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Perez Paul, MD study chair
Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique du CHU de Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroenteritis, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive Campylobacter detection with ICT (time frame: The day of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.