Community Epidemiology and Typology of Third-generation Cephalosporins Resistant Enterobacteriaceae in Reunion Island

NCT03226314 | Unknown

• 1 other identifier: 2015/CHU/14
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacterial Resistance

Keywords

bacterial multi-resitance

Outcome Measures

Primary Outcomes (1)

• Digestive prevalence rate of 3GCREB

  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

Study Arms (1)

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.

Procedure: stool sample

Interventions

stool sample PROCEDURE

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.

stool sampled community patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

Chu Reunion Island

Saint-Pierre, Reunion Island, 97410, Reunion

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

stools samples

Study Officials

• Julien JAUBERT, MD

  CHU La Réunion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: July 21, 2017
• Study Start: November 21, 2017
• Primary Completion: December 1, 2018
• Study Completion: June 30, 2019
• Last Updated: March 7, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

RE (1)