Clinical trial NCT02799225: Prevalence of Clinical Strains of Enterobacteria With Reduced Susceptibility to Carbapenems in the North-West Region of France
Official title: Prevalence of Clinical Strains of Enterobacteria With Reduced Susceptibility to Carbapenems in the North-West Region of France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enterobacteriaceae
Keywords: carbapenems
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing bacteriological samples as part of routine clinical practice during their hospital stay in one of the 6 participating centres. Patients in whom the results of bacteriological examinations reveal the presence of an Enterobacteria strain with reduced susceptibility to carbapenems will be included in this project

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.


Eligibility criteria: 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).

Primary outcomes:
measure: prevalence of clinical strains of Enterobacteria
timeFrame: 1 year
Secondary outcomes:
measure: characterization of the mechanisms responsible for carbapenems resistance
timeFrame: 1 year
Other outcomes:
Locations:
city: Abbeville
country: France
facility: CH Abbeville
city: Amiens
country: France
facility: CHU Amiens
city: Beauvais
country: France
facility: CH Beauvais
city: Caen
country: France
facility: CHU Caen
city: Compiegne
country: France
facility: CHU Compiegne
city: Lille
country: France
facility: CHRU Lille
Study officials:
affiliation: CHU Amiens
name: Hedi MAMMERI, PhD
role: PRINCIPAL_INVESTIGATOR
References: