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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
Recruitment status was: Recruiting
Sponsor:
University of Siena
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
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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 |
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) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00404625
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 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 |
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 July 19, 2017