Clinical Trial: Infections Caused by ESbL-Producing Enterobacteriaceae in Italy

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Infections Caused by Enterobacteriaceae Producing Extended-Spectrum β-Lactamases in Italy: Molecular Epidemiology, Clinical Impact, Treatment Outcome and Risk Factors

Brief Summary:

To assess the molecular epidemiology, clinical impact, treatment outcome and risk factors for infections caused by Enterobacteriaceae producing ESBLs in Italy in a large multicenter observational survey.

SPECIFIC OBJECTIVES

  1. To collect consecutive nonreplicate isolates of Enterobacteriaceae resistant to expanded-spectrum cephalosporins from clinical specimens from inpatients and outpatients.
  2. To characterize the isolates for resistance phenotypes and for β-lactam resistance mechanisms.
  3. To investigate the clonality of isolates.
  4. To analyse the epidemiology of various resistance mechanisms/resistant clones.
  5. To collect clinical and epidemiological data for patients with infections caused by the ESBL producers.
  6. To analyse the epidemiology, risk factors and outcome for infections caused by ESBL producers.

Detailed Summary:

RESEARCH PLAN AND METHODOLOGY

Population All patients with infections (i.e. bacteremia, pneumonia, abdomen infections, skin infections, and urinary tract infections) caused by ESBL-producing Enterobacteriaceae.

Exclusion criteria Children < 16 years

Trial design Multicenter prospective cohort study. Patients corresponding to the study definition will be detected by daily inspection of microbiological databases by one dedicated physician. Epidemiological variables will be detected for all patients at study admission. To identify the risk factors for infections (i.e. bacteremia, pneumonia, abdomen infections, skin infections, and urinary tract infections) caused by ESBL-producing Enterobacteriaceae a case-control study will be performed. A case patient will be defined as adult patient ( 16 years of age) who has an infection caused by ESBL-producing Enterobacteriaceae according to the definitions of the Center for Diseases Control and Prevention in Atlanta (CDC). In the Clinical Microbiology Laboratories, definition of ESBL production by the Clinical Microbiology Laboratories will be according to the CLSI guidelines (3), or to the BSAC guidelines (http://www.bsac.org.uk) for species other than Klebsiella spp., E. coli and Proteus mirabilis. One control will be selected for each case. Control will be chosen among all adult patients admitted to the same hospital during the same period (within 30 days) and in whom ESBL-producing Enterobacteriaceae were not isolated during their hospital stay. If more than one control will be available per case, patients with the date and time of admission closest to the case will be chosen.

To identify the risk factors for mortality a second case-control study will be performed comparin
Sponsor: University of Siena

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Siena

Dates:
Date Received: November 28, 2006
Date Started: October 2006
Date Completion: November 2006
Last Updated: November 28, 2006
Last Verified: November 2006