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

Enterobacteriaceae Clinical Trial

— ERC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02799225
• Other study ID #: PHRCIR11-DR-MAMMERI
• Status: Completed
• Phase: N/A
• First received: June 10, 2016
• Last updated: January 30, 2017
• Start date: June 2012
• Est. completion date: February 2, 2014

Study information

• Verified date: January 2017
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: February 2, 2014
• Est. primary completion date: February 2, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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).

Related Conditions & MeSH terms

• Disease Susceptibility
• Enterobacteriaceae

Locations

Country	Name	City	State
France	CH Abbeville	Abbeville
France	CHU Amiens	Amiens
France	CH Beauvais	Beauvais
France	CHU Caen	Caen
France	CHU Compiegne	Compiegne
France	CHRU Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of clinical strains of Enterobacteria		1 year
Secondary	characterization of the mechanisms responsible for carbapenems resistance		1 year