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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:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University of Siena
ClinicalTrials.gov Identifier:
NCT00404625
First received: November 28, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  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

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404625

Locations
Italy
Università Politecnica delle Marche
Ancona, Italy, 60100
A.O. “Ospedali Riuniti di Bergamo”
Bergamo, Italy, 24128
Univeristà di Firenze, Ospedale Careggi
Firenze, Italy, 50134
Ospedale Niguarda Ca' Granda
Milano, Italy, 20159
Università Cattolica S. Cuore, Policlinico Gemelli
Roma, Italy, 00168
Università di Varese
Varese, Italy, 21100
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 
Study First Received: November 28, 2006
Last Updated: November 28, 2006
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on December 07, 2016