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)

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.

Study Overview

• Status: Completed
• Conditions: STAPHYLOCOCCAL INFECTIONS
• Intervention / Treatment: Other: Staphylococcus aureus carriage

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Etienne, France, 42055
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patient with Staphylococcus aureus colonic carriage	Staphylococcus aureus carriage in the colon is measured by biopsy	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1
Number of patient with Staphylococcus aureus carriage in the nose	Staphylococcus aureus carriage in the nose is measured by swab culture.	Day 1
Number of patient with Staphylococcus aureus carriage in the throat	Staphylococcus aureus carriage in the throat is measured by swab culture.	Day 1
Number of patient with Staphylococcus aureus carriage in the groin	Staphylococcus aureus carriage in the groin is measured by swab culture.	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Philippe Berthelot, PhD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2015
• Primary Completion (Actual): October 20, 2017
• Study Completion (Actual): October 20, 2017

Study Registration Dates

• First Submitted: July 15, 2015
• First Submitted That Met QC Criteria: July 16, 2015
• First Posted (Estimate): July 20, 2015

Study Record Updates

• Last Update Posted (Actual): September 28, 2018
• Last Update Submitted That Met QC Criteria: September 27, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: staphylococcus aureus; digestive carriage; mucosal colonization
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Staphylococcal Infections
• Other Study ID Numbers: 1408023; 2014-A00755-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No