STAPHYLOCOCCAL INFECTIONSColoStaphNCT02502474
Study of the Colonic Carriage of Staphylococcus Aureus in a Prospective Cohort of Patients Undergoing Endoscopic Screening for Digestive Cancer in the University Hospital of Saint-Etienne
A study testing Staphylococcus aureus carriage in people with STAPHYLOCOCCAL INFECTIONS, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Epidemiological study aiming to describe the carriage (nasal, throat, groin, rectal and colonic) of S. aureus in patients without chronic digestive disease who are going to have a colonoscopy for cancer screening. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- STAPHYLOCOCCAL INFECTIONS
- What is being tested?
- Staphylococcus aureus carriage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2015to 20 Oct 2017
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient affiliated to French social security
- Written consent of the patient
- Patient needing a colonoscopy in the University Hospital of Saint-Etienne, France
Who cannot join
- Patient who decline to participate to the study
- Patient in the incapacity to give consent
- Patient receiving treatment with anticoagulant or antiaggregant platelets
- Patients with a known haemostatic disorder
- Pregnant woman
- Patients with a chronic disease of the gastrointestinal tract
- Patients receiving long-term corticosteroid
- Patient receiving anti staphylococcal antibiotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Colonic Carriage of Staphylococcus Aureus in a Prospective Cohort of Patients Undergoing Endoscopic Screening for Digestive Cancer in the University Hospital of Saint-Etienne.
Epidemiological study aiming to describe the carriage (nasal, throat, groin, rectal and colonic) of S. aureus in patients without chronic digestive disease who are going to have a colonoscopy for cancer screening. The carriage will be analyzed globally and the similarity of strains isolated from each site will be analyzed using molecular tools. The aim of this study is to better estimate the digestive reservoir of S. aureus to better prevent endogenous infections due to this bacterium.
- Conditions
- STAPHYLOCOCCAL INFECTIONS
- Being tested
- Staphylococcus aureus carriage
- Keywords
- staphylococcus aureus, digestive carriage, mucosal colonization
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staphylococcus aureus carriageOther
nasal, throat, rectal and groin sampling with swabs. Colonic sampling by colonic biopsy
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing a colonoscopy | Experimental | Staphylococcus aureus carriage is measured in nose, throat, colon, rectum and groin Receives: Other: Staphylococcus aureus carriage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient with Staphylococcus aureus colonic carriage
Staphylococcus aureus carriage in the colon is measured by biopsy
Measured: Day 1
Secondary outcomes (4)
Number of patient with similar Staphylococcus aureus strains in the nose and in the rectum
Staphylococcus aureus carriage in the rectum and in the nose is measured by swab culture
Measured: Day 1
Number of patient with Staphylococcus aureus carriage in the nose
Staphylococcus aureus carriage in the nose is measured by swab culture.
Measured: Day 1
Number of patient with Staphylococcus aureus carriage in the throat
Staphylococcus aureus carriage in the throat is measured by swab culture.
Measured: Day 1
Number of patient with Staphylococcus aureus carriage in the groin
Staphylococcus aureus carriage in the groin is measured by swab culture.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study start2 Feb 2015
- Primary completion20 Oct 2017
- Study completion20 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STAPHYLOCOCCAL INFECTIONSStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Berthelot, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502474
- Sponsor's protocol ID
- 1408023
- Other IDs
- 2014-A00755-42
- Acronym
- ColoStaph
- Status last verified
- Sep 2018
- First submitted
- 15 Jul 2015
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Colonic Carriage of Staphylococcus Aureus in a Prospective Cohort of Patients Undergoing Endoscopic Screening for Digestive Cancer in the University Hospital of Saint-Etienne.
- ClinicalTrials.gov ID
- NCT02502474
- Acronym / sponsor ID
- ColoStaph / 1408023
- Conditions
- STAPHYLOCOCCAL INFECTIONS
- Keywords
- staphylococcus aureus, digestive carriage, mucosal colonization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 2 Feb 2015 (actual)
- Primary completion
- 20 Oct 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 20 Jul 2015 (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.
Epidemiological study aiming to describe the carriage (nasal, throat, groin, rectal and colonic) of S. aureus in patients without chronic digestive disease who are going to have a colonoscopy for cancer screening. The carriage will be analyzed globally and the similarity of strains isolated from each site will be analyzed using molecular tools. The aim of this study is to better estimate the digestive reservoir of S. aureus to better prevent endogenous infections due to this bacterium.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing a colonoscopy | Experimental | Other: Staphylococcus aureus carriageStaphylococcus aureus carriage is measured in nose, throat, colon, rectum and groin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient affiliated to French social security
- Written consent of the patient
- Patient needing a colonoscopy in the University Hospital of Saint-Etienne, France
Key exclusion criteria (8 listed)
- Patient who decline to participate to the study
- Patient in the incapacity to give consent
- Patient receiving treatment with anticoagulant or antiaggregant platelets
- Patients with a known haemostatic disorder
- Pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Staphylococcus aureus carriagenasal, throat, rectal and groin sampling with swabs. Colonic sampling by colonic biopsy | Other | Patients undergoing a colonoscopy |
Primary outcome
Number of patient with Staphylococcus aureus colonic carriage
Time frame: Day 1
Staphylococcus aureus carriage in the colon is measured by biopsy
4 secondary outcomes
Number of patient with similar Staphylococcus aureus strains in the nose and in the rectum
Time frame: Day 1
Number of patient with Staphylococcus aureus carriage in the nose
Time frame: Day 1
Number of patient with Staphylococcus aureus carriage in the throat
Time frame: Day 1
Number of patient with Staphylococcus aureus carriage in the groin
Time frame: Day 1
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 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Philippe Berthelot, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staphylococcus aureus carriage in people with STAPHYLOCOCCAL INFECTIONS, run by Centre Hospitalier Universitaire de Saint Etienne 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 3 inclusion and 8 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 Sep 2018. 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?
Number of patient with Staphylococcus aureus colonic carriage (time frame: Day 1). 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 Sep 2018.