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Infections Caused by ESbL-Producing Enterobacteriaceae in Italy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by University of Siena.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00404625
First Posted: November 29, 2006
Last Update Posted: November 29, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University of Siena
  Purpose

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.

Condition Intervention
Enterobacteriaceae Infections Bacteremia Pneumonia Skin Diseases Urinary Tract Infections Behavioral: Risk factors for infections due to ESBL+ Enterobacteriaceae Behavioral: Risk factors for inadequate initial antimicrobial therapy Behavioral: Overall and 30-day mortality in bad first antibiotic therapy

Study Type: Observational
Study Design: Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Infections Caused by Enterobacteriaceae Producing Extended-Spectrum β-Lactamases in Italy: Molecular Epidemiology, Clinical Impact, Treatment Outcome and Risk Factors

Further study details as provided by University of Siena:

Estimated Enrollment: 813
Study Start Date: October 2006
Estimated Study Completion Date: November 2006
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404625


Contacts
Contact: Gian Maria Rossolini, professore +39 0577 233455 rossolini@unisi.it

Locations
Italy
Università Politecnica delle Marche Recruiting
Ancona, Italy, 60100
Contact: Giorgio Scalise, MD         
A.O. “Ospedali Riuniti di Bergamo” Recruiting
Bergamo, Italy, 24128
Contact: Fredy Suter, MD         
Univeristà di Firenze, Ospedale Careggi Recruiting
Firenze, Italy, 50134
Contact: Franco Paradisi, Professore         
Ospedale Niguarda Ca' Granda Recruiting
Milano, Italy, 20159
Contact: Liliana Caggese, MD         
Università Cattolica S. Cuore, Policlinico Gemelli Recruiting
Roma, Italy, 00168
Contact: Roberto Cauda, Professore         
Principal Investigator: Evelina Tacconelli, MD         
Università di Varese Recruiting
Varese, Italy, 21100
Contact: Paolo Grossi, MD         
Sponsors and Collaborators
University of Siena
Merck Sharp & Dohme Corp.
Investigators
Study Chair: Gian Maria Rossolini, professore Università di Siena
  More Information

ClinicalTrials.gov Identifier: NCT00404625     History of Changes
Other Study ID Numbers: P1908
First Submitted: November 28, 2006
First Posted: November 29, 2006
Last Update Posted: November 29, 2006
Last Verified: November 2006

Keywords provided by University of Siena:
Bacteremia caused by ESBL-producing Enterobacteriaceae
Pneumonia caused by ESBL-producing Enterobacteriaceae
Abdomen infections due to ESBL-producing Enterobacteriaceae
Skin infections caused by ESBL-producing Enterobacteriaceae
Urinary infections due to ESBL-producing Enterobacteriaceae

Additional relevant MeSH terms:
Infection
Communicable Diseases
Pneumonia
Urinary Tract Infections
Bacteremia
Skin Diseases
Enterobacteriaceae Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Urologic Diseases
Bacterial Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Gram-Negative Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents