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
2 other identifiers
interventional
112
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 2, 2015
CompletedFirst Submitted
Initial submission to the registry
July 15, 2015
CompletedFirst Posted
Study publicly available on registry
July 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2017
CompletedSeptember 28, 2018
September 1, 2018
2.7 years
July 15, 2015
September 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patient with Staphylococcus aureus colonic carriage
Staphylococcus aureus carriage in the colon is measured by biopsy
Day 1
Secondary Outcomes (4)
Number of patient with similar Staphylococcus aureus strains in the nose and in the rectum
Day 1
Number of patient with Staphylococcus aureus carriage in the nose
Day 1
Number of patient with Staphylococcus aureus carriage in the throat
Day 1
Number of patient with Staphylococcus aureus carriage in the groin
Day 1
Study Arms (1)
Patients undergoing a colonoscopy
EXPERIMENTALStaphylococcus aureus carriage is measured in nose, throat, colon, rectum and groin
Interventions
nasal, throat, rectal and groin sampling with swabs. Colonic sampling by colonic biopsy
Eligibility Criteria
You may qualify if:
- Patient affiliated to French social security
- Written consent of the patient
- Patient needing a colonoscopy in the University Hospital of Saint-Etienne, France
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Saint-Etienne
Saint-Etienne, 42055, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe Berthelot, PhD
CHU SAINT-ETIENNE
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2015
First Posted
July 20, 2015
Study Start
February 2, 2015
Primary Completion
October 20, 2017
Study Completion
October 20, 2017
Last Updated
September 28, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share