Infections Caused by ESbL-Producing Enterobacteriaceae in Italy
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|ClinicalTrials.gov 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
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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.
- 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 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|
|Study Type :||Observational|
|Enrollment :||813 participants|
|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|
- All patients with infections (i.e. bacteremia, pneumonia, abdomen infections, skin infections, and urinary tract infections) caused by ESBL-producing Enterobacteriaceae
- Children < 16 years
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
|Contact: Gian Maria Rossolini, professore||+39 0577 firstname.lastname@example.org|
|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|
|Study Chair:||Gian Maria Rossolini, professore||Università di Siena|
|Other Study ID Numbers:||
|First Posted:||November 29, 2006 Key Record Dates|
|Last Update Posted:||November 29, 2006|
|Last Verified:||November 2006|
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
Urinary Tract Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases
Bacterial Infections and Mycoses
Systemic Inflammatory Response Syndrome
Gram-Negative Bacterial Infections