Epidemiological Study of Intestinal Colonization With Staphylococcus Aureus (DigeSTAPH)

March 22, 2016 updated by: Centre Hospitalier Universitaire de Saint Etienne

Epidemiological Study of Intestinal Colonization With Staphylococcus Aureus in a Cohort of Adult Patients Hospitalized in Intensive Care at the University Hospital of St Etienne.

Nasal colonization with S. aureus is a risk factor for infection with this bacterium. A methodologically well conducted study of S. aureus bacteremia showed that 80% of S. aureus bacteremia with are due to the strain isolated in the nasal level. However, as part of a study coordinated by the CHU of Saint-Etienne, less than 50% of infections in prosthetic orthopedic devices have been linked to nasal carriage . Outside of exogenous infections, intestinal colonization with S. aureus could be an alternative source of endogenous infections with the waning of orthopedic surgery. In the general population, considering that about one third of the subjects were colonized with S. aureus nasal level and 1 in 5 in the intestine However the proportion of exclusive intestinal porting is not well known .

This study will analyze, among ICU patients, porting S. aureus nasal and rectal level. It will better clarify the relationship between nasal and rectal ports and the risk of developing an infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The adult patients hospitalized in intensive care at the University Hospital of Saint-Etienne have a multiresistant bacteria porting screening at the nose and rectum at admission and then once a week. These samples will be carried unchanged way for the study but will also be a research S Aureus

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • St Etienne, France, 42000
        • CHU de Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized in intensive care

Description

Inclusion Criteria:

  • patients hospitalized in intensive care and benefiting from a screening multiresistant bacteria in nasal and rectal level under routine care

Exclusion Criteria:

  • refusal of the patient's family

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nasal and rectal samples
ICU patients with nasal and rectal bacterial samples for the presence of S Aureus
Procedure: Nasal and rectal bacterial samples
Bacterial nasal and rectal samples at admission and one weekly for the presence of S Aureus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of S. aureus colonization at rectal level
Time Frame: 1 month
The presence of a colony of S. aureus on one of the samples
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
S. aureus strains similar to nasal and rectal level
Time Frame: 1 month
S. aureus strains similar in molecular typing
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Philippe BERTHELOT, Md-PhD, CHU Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

September 9, 2015

First Submitted That Met QC Criteria

September 9, 2015

First Posted (Estimate)

September 11, 2015

Study Record Updates

Last Update Posted (Estimate)

March 23, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1208087
  • 2012-A01182-41 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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