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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 (ColoStaph)

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ClinicalTrials.gov Identifier: NCT02502474
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief 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. 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.

Condition or disease Intervention/treatment Phase
STAPHYLOCOCCAL INFECTIONS Other: Staphylococcus aureus carriage Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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.
Actual Study Start Date : February 2, 2015
Actual Primary Completion Date : October 20, 2017
Actual Study Completion Date : October 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients undergoing a colonoscopy
Staphylococcus aureus carriage is measured in nose, throat, colon, rectum and groin
Other: Staphylococcus aureus carriage
nasal, throat, rectal and groin sampling with swabs. Colonic sampling by colonic biopsy




Primary Outcome Measures :
  1. Number of patient with Staphylococcus aureus colonic carriage [ Time Frame: Day 1 ]
    Staphylococcus aureus carriage in the colon is measured by biopsy


Secondary Outcome Measures :
  1. Number of patient with similar Staphylococcus aureus strains in the nose and in the rectum [ Time Frame: Day 1 ]
    Staphylococcus aureus carriage in the rectum and in the nose is measured by swab culture

  2. Number of patient with Staphylococcus aureus carriage in the nose [ Time Frame: Day 1 ]
    Staphylococcus aureus carriage in the nose is measured by swab culture.

  3. Number of patient with Staphylococcus aureus carriage in the throat [ Time Frame: Day 1 ]
    Staphylococcus aureus carriage in the throat is measured by swab culture.

  4. Number of patient with Staphylococcus aureus carriage in the groin [ Time Frame: Day 1 ]
    Staphylococcus aureus carriage in the groin is measured by swab culture.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient affiliated to French social security
  • Written consent of the patient
  • Patient needing a colonoscopy in the University Hospital of Saint-Etienne, France

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502474


Locations
France
CHU Saint-Etienne
Saint-Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Philippe Berthelot, PhD CHU Saint-Etienne

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02502474     History of Changes
Other Study ID Numbers: 1408023
2014-A00755-42 ( Other Identifier: ANSM )
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
staphylococcus aureus
digestive carriage
mucosal colonization

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections