Linezolid-resistant Staphylococcus Epidermidis in ICU and Risk Factors Analysis

NCT03140410 | Unknown

• 1 other identifier: CHUBesancon
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Care Associated Infection; Antibiotic Resistant Strain; Infection Transmission

Keywords

Staphylococci; Blood-stream infections; Linezolid

Outcome Measures

Primary Outcomes (1)

• linezolid-resistance

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

  within the 28 days after diagnosis of blood stream infection, or identification of the first blood culture positive with S. epdermidis

Secondary Outcomes (1)

• mutations rate regarding crf gene

  retrospective analysis, 1 to 5 years after blood stream infection diagnosis

Other Outcomes (1)

• linezolid consumption at the time of diagnosis (quantified by the defined daily dose)

  retrospective analysis, 1 to 5 years after blood stream infection diagnosis

Study Arms (2)

Linezolid-resistant S. epidermidis

Patients affected by blood stream infections caused by meticillin-resistant S.epidermidis strains, tested resistant to linezolid

Other: Antibiotic resistance

Linezolid-susceptible S.epidermidis

Patients affected by blood stream infections caused by meticillin-resistant S.epidemridis strains, tested susceptible to linezolid

Other: Antibiotic resistance

Interventions

Antibiotic resistance OTHER

Test for susceptibility to linezolid using phenotypic tests, according to guidance from EUCAST group. Screening for the presence of "crf" gene, and mutations associated

Linezolid-resistant S. epidermidis; Linezolid-susceptible S.epidermidis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

critically ill patients admitted at one of the two 20-beds ICU of our teaching hospital, with no regard to the reason for admission, neither to conditions at admission or severity of illness, nor to prognosis of affection leading to ICU

You may qualify if:

• all adult patient admitted in ICU between april 2011 and october 2016, diagnosed for a blood stream infection during the ICU stay, whatever the antibiotic therapy conducted before or after the diagnosis

You may not qualify if:

• minor-aged patients
• less than 2 blood cultures positive
• blood cultures distant from more than 48 hours
• cultures positive to distinct pathogens

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU Jean Minjoz

Besançon, 25000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stapylococcus epidermidis meticillin-resistant strains, isolated from blood cultures

MeSH Terms

Conditions

Cross Infection

Interventions

Drug Resistance, Microbial

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Microbiological Phenomena; Drug Resistance; Pharmacological Phenomena; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Study Officials

• Xavier Bertrand, MD,PhD

  Service d'Hygiène Hospitalière, CHU Jean Minjoz Besançon - Université de Franche-Comté, Faculté de Sciences Médicales et Pharmaceutiques

  STUDY DIRECTOR

• Catherine Chirouze, MD,PhD

  Service de Maladies Infectieuses et Tropicales, CHU Jean Minjoz Besançon - Université de Franche-Comté, Faculté de Sciences Médicales et Pharmaceutiques

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 29, 2017
• First Posted: May 4, 2017
• Study Start: April 28, 2017
• Primary Completion: October 20, 2017
• Study Completion: January 2, 2018
• Last Updated: September 12, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)