Community Epidemiology and Typology of Third-generation Cephalosporins Resistant Enterobacteriaceae in Reunion Island (AB-RUN)

Community Epidemiology and Typology of Third-generation Cephalosporins Resistant Enterobacteriaceae (Prevalence, Resistance Mechanisms and Risk Factors) in Reunion Island

In its report dated april 2014, World Health Organization confirms antibiotic resistance dissemination in all parts of the world, in hospitals and in community and worries about a possible comeback to a pre-antibiotic era during the 21st century. For the last 15 years, third-generation cephalosporins resistant enterobacteriaceae (3GCREB) prevalence is continuously increasing. Community 3GCREB prevalence has not been studied whereas several observations made in Reunion Island hospital suggest a diffusion in community. In this situation of world-wide and regional extension of bacterial resistance, the investigator offers to study bacterial resistance to antibiotic in Reunion Island community.

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

The investigator is focused on E. coli species exhibiting BLSE or metallo-betalactamases production that could be encountered du to the increasing level of migratory flow in Reunion Island.

Fecal sample collection will be used for further investigations on bacterial typology.

Study Type

Observational

Enrollment (Actual)

500

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

    • Reunion Island
      • Saint-Pierre, Reunion Island, Réunion, 97410
        • CHU Reunion Island

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

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

community patients admitted in emergency ward or in intensive care unit for any condition.

Description

Inclusion Criteria:

Patients:

  • aged over 18 years old
  • admitted in emergency ward or intensive care of the university hospital of Reunion Island
  • who received the patient information notice and who gave their consent
  • who have a stool sample performed in the 48 hours following admission
  • who understand and can read French

Exclusion Criteria:

Patients:

  • transferred from a short-term, middle-term or long-term stay health facility
  • who have a stool sample performed more than 48 hours following admission.

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
stool sampled community patients
community patients entering emergency ward or intensive care unit in Reunion Island university hospital and having the stools sampled for bacterial analysis.
study will be proposed to all patients entering emergency ward or intensive care unit in Reunion Island university hospital. Upon consent, a stool sample will be taken (either directly on emitted stools or by rectal sampling) and analysed for enterobacteriaceae.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Digestive prevalence rate of 3GCREB
Time Frame: through study completion, an average of 1 day
estimate of digestive prevalence rate of 3GCREB in participating patients and extrapolation to Reunion Island community population.
through study completion, an average of 1 day

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Julien JAUBERT, MD, CHU La Réunion

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 (ACTUAL)

November 21, 2017

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ANTICIPATED)

June 30, 2019

Study Registration Dates

First Submitted

March 3, 2017

First Submitted That Met QC Criteria

July 20, 2017

First Posted (ACTUAL)

July 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2015/CHU/14

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

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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