search
Back to results

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)

Primary Purpose

STAPHYLOCOCCAL INFECTIONS

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Staphylococcus aureus carriage
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for STAPHYLOCOCCAL INFECTIONS focused on measuring staphylococcus aureus, digestive carriage, mucosal colonization

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Saint-Etienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients undergoing a colonoscopy

Arm Description

Staphylococcus aureus carriage is measured in nose, throat, colon, rectum and groin

Outcomes

Primary Outcome Measures

Number of patient with Staphylococcus aureus colonic carriage
Staphylococcus aureus carriage in the colon is measured by biopsy

Secondary Outcome Measures

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
Number of patient with Staphylococcus aureus carriage in the nose
Staphylococcus aureus carriage in the nose is measured by swab culture.
Number of patient with Staphylococcus aureus carriage in the throat
Staphylococcus aureus carriage in the throat is measured by swab culture.
Number of patient with Staphylococcus aureus carriage in the groin
Staphylococcus aureus carriage in the groin is measured by swab culture.

Full Information

First Posted
July 15, 2015
Last Updated
September 27, 2018
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
search

1. Study Identification

Unique Protocol Identification Number
NCT02502474
Brief 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
Acronym
ColoStaph
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 2, 2015 (Actual)
Primary Completion Date
October 20, 2017 (Actual)
Study Completion Date
October 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STAPHYLOCOCCAL INFECTIONS
Keywords
staphylococcus aureus, digestive carriage, mucosal colonization

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients undergoing a colonoscopy
Arm Type
Experimental
Arm Description
Staphylococcus aureus carriage is measured in nose, throat, colon, rectum and groin
Intervention Type
Other
Intervention Name(s)
Staphylococcus aureus carriage
Intervention Description
nasal, throat, rectal and groin sampling with swabs. Colonic sampling by colonic biopsy
Primary Outcome Measure Information:
Title
Number of patient with Staphylococcus aureus colonic carriage
Description
Staphylococcus aureus carriage in the colon is measured by biopsy
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Number of patient with similar Staphylococcus aureus strains in the nose and in the rectum
Description
Staphylococcus aureus carriage in the rectum and in the nose is measured by swab culture
Time Frame
Day 1
Title
Number of patient with Staphylococcus aureus carriage in the nose
Description
Staphylococcus aureus carriage in the nose is measured by swab culture.
Time Frame
Day 1
Title
Number of patient with Staphylococcus aureus carriage in the throat
Description
Staphylococcus aureus carriage in the throat is measured by swab culture.
Time Frame
Day 1
Title
Number of patient with Staphylococcus aureus carriage in the groin
Description
Staphylococcus aureus carriage in the groin is measured by swab culture.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Berthelot, PhD
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs