Infections Caused by ESbL-Producing Enterobacteriaceae in Italy

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2006 by University of Siena. Recruitment status was Recruiting

First Received on November 28, 2006. No Changes Posted

Sponsor:	University of Siena
Collaborator:	Merck
Information provided by:	University of Siena
ClinicalTrials.gov Identifier:	NCT00404625

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

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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia Skin Conditions Urinary Tract Infections

U.S. FDA Resources

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
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

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

Investigators

Study Chair:

Gian Maria Rossolini, professore

Università di Siena

More Information

No publications provided

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:

Bacteremia
Enterobacteriaceae Infections
Pneumonia
Skin Diseases
Urinary Tract Infections
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation

Pathologic Processes
Gram-Negative Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Urologic Diseases
Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012