Infections Caused by ESbL-Producing Enterobacteriaceae in Italy

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. Identifier: NCT00404625
Recruitment Status : Unknown
Verified November 2006 by University of Siena.
Recruitment status was:  Recruiting
First Posted : November 29, 2006
Last Update Posted : November 29, 2006
Merck Sharp & Dohme Corp.
Information provided by:
University of Siena

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.


  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 or disease Intervention/treatment
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

  Show Detailed Description

Study Type : Observational
Enrollment : 813 participants
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
Study Start Date : October 2006
Study Completion Date : November 2006

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

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

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 identifier (NCT number): NCT00404625

Contact: Gian Maria Rossolini, professore +39 0577 233455

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.
Study Chair: Gian Maria Rossolini, professore Università di Siena Identifier: NCT00404625     History of Changes
Other Study ID Numbers: P1908
First Posted: November 29, 2006    Key Record Dates
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:
Communicable Diseases
Urinary Tract Infections
Skin Diseases
Enterobacteriaceae Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Urologic Diseases
Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Gram-Negative Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents