Clinical Trial: Linezolid-resistant Staphylococcus Epidermidis in ICU and Risk Factors Analysis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Evaluation of the Emergence of the Resistance to Linezolid in Staphylococcus Epidermidis and Risk Factors Analysis : a Mono-centric Case-control Study

Brief Summary:

Understanding the emergence of linezolid-resistance in Staphylococci has been allowed in the past years through the discovery of the clonal dissemination of a chromosomal cassette carrying a modified crf gene. New mutations have even been described. Though, clinical evidences are still lacking, especially concerning the factors associated to this emergence. It could seriously become quite problematic to eliminate one of the last therapeutic weapon at our disposal for the treatment of severe or complicated infections caused by resistant strains of Staphylococci and Enterococci.

We aim to describe the mechanisms that permitted to this resistance to become clinically significant, concerning meticillin-resistant Staphyloccocus epidermidis strains causing blood stream infections in ICU patients, and show the clinical risk factors associated with it through a case-control study on patients hospitalized in two ICUs of our hospital between 2011 and 2016.


Detailed Summary:

Resistance to linezolid has been increasing in the past years, suggesting growing therapeutic difficulties while narrowing the options for treating severe or complicated infections involving Staphyloccoci or Enterococci strains. This emergence has been partially explained after the discovery of chromosomal dissemination of a particular gene, named "crf", conferring high level resistance to oxazolidinones.

Moreover, this mechanism has been showed as being prevalent in several countries across North America, Asia, and Europe.

But still the link with clinical evidences has not yet been very well established.

In particular the role of S. epidermidis has become clinically significant concerning blood stream infections and catheter-linked infections. The reality of the pathogenicity is more widely accepted, especially regarding prosthetic joint infections, and immunocompromised patient, as in hematology and oncology.

Thus, it appears necessary to provide more solid informations concerning the risk of using this antibiotic in a high burden setting of resistance, where it might be prescribed intensively on critical situations, and thus responsible for a high selection pressure of resistance.

We aim to describe the emergence of the resistance to linezolid in meticillin-resistant S. epidermidis strains in the two 20-beds ICUs of our Teaching Hospital, in the 5 past years, between april 2011 and october 2016.

We conduct a case-control study between two populations of patients hospitalized in one of these ICU.

They all presented a blood stream infection caused by a strain of S. e
Sponsor: Centre Hospitalier Universitaire de Besancon

Current Primary Outcome: linezolid-resistance [ Time Frame: within the 28 days after diagnosis of blood stream infection, or identification of the first blood culture positive with S. epdermidis ]

searching for risk factors associated with blood stream infection due to a linezolid-resistant S.epidemridis strain


Original Primary Outcome: Same as current

Current Secondary Outcome: mutations rate regarding crf gene [ Time Frame: retrospective analysis, 1 to 5 years after blood stream infection diagnosis ]

systematic search through genotypic study through pulsed field gel electrophoresis


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Besancon

Dates:
Date Received: April 29, 2017
Date Started: April 28, 2017
Date Completion: June 2, 2017
Last Updated: May 3, 2017
Last Verified: May 2017