- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03226314
Community Epidemiology and Typology of Third-generation Cephalosporins Resistant Enterobacteriaceae in Reunion Island (AB-RUN)
March 6, 2019 updated by: Centre Hospitalier Universitaire de la Réunion
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
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
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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.
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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
Keywords
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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