Prevalence of Clinical Strains of Enterobacteria With Reduced Susceptibility to Carbapenems in the North-West Region of France

Completed

• Conditions: Enterobacteriaceae

• Registration Number: NCT02799225
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

Enterobacteria constitute a family of Gram negative bacilli of the gastrointestinal flora. These micro-organisms are frequently responsible for nosocomial or community-acquired infections, for which treatment is essentially based on the use of beta-lactam antibiotics. This class of antibiotics comprises penicillins, cephalosporins, monobactams and carbapenems. Carbapenems have the advantage of possessing a broad antibacterial spectrum and the capacity to resist the hydrolytic action of a large number of beta-lactamases, widespread inactivating enzymes.

However, new enzymes, called carbapenemases, able to confer resistance to carbapenems either alone or in combination with additional resistance mechanisms such as loss of membrane permeability or overexpression of efflux systems, are currently emerging all over the world. Carbapenemases represent a major public health problem because of the risk of therapeutic impasse and their high epidemic potential.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2014-02-02
• Study Completion: 2014-02-02
• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-14
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

Inclusion Criteria

• Patients in whom the results of bacteriological examinations reveal the presence of an Enterobacteria strain with reduced susceptibility to carbapenems
• Control : patients ( infected or colonized ) a strain of Enterobacter sensitive to carbapenems immediately isolated after a strain of Enterobacter having decreased susceptibility to carbapenems from the same service and same hospital ( 2 strains susceptible strain with reduced sensitivity).

Exclusion Criteria

• Duplicate : same strain to a first strain of reduced sensitivity in isolated the same patient during the study period ( same bacterial species , even after characterization resistance mechanism).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prevalence of clinical strains of Enterobacteria	1 year

Secondary Outcome Measures

Name	Time	Method
characterization of the mechanisms responsible for carbapenems resistance	1 year

Trial Locations

Locations (6)

CH Abbeville; 🇫🇷 Abbeville, France

CHU Amiens; 🇫🇷 Amiens, France

CHRU Lille; 🇫🇷 Lille, France

CHU Caen; 🇫🇷 Caen, France

CHU Compiegne; 🇫🇷 Compiegne, France

CH Beauvais; 🇫🇷 Beauvais, France