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A multi-center, retrospective study of cases of serious bacterial infections including complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP), Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Acquired Bacterial Pneumonia (VABP), and/or bacteremia caused by Carbapenem-Resistant Enterobacteriaceae (CRE)
This multi-center, retrospective study of cases of serious bacterial infections (including cUTI or AP, HABP, VABP, and/or bacteremia caused by CRE) will consist of a chart review over a 6 month period from September 1, 2013 to March 1, 2014. De-identified data will be collected from the chart review of at least 150 cases of selected infections due to CRE at approximately 20 sites.
The study itself is strictly observational and retrospective, with no direct study-related patient interaction, treatment, or testing. There will be no patient identifying data collected as part of this study.
Charts of patients who meet study-defined criteria for cUTI or AP, HABP, VABP, and/or bacteremia and have a culture from the site of infection or the blood that is positive for a Carbapenem-Resistant Enterobacteriaceae will be reviewed.
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of positive CRE infections (specifically cUTI, AP, HABP, VABP, Bacteremia) in a target patient population | 6 month period from September 1, 2013 to March 1, 2014 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with serious CRE infections identified by chart review at up to 20 sites
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| Name | Affiliation | Role |
|---|---|---|
| Karen Fusaro | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chicago | Illinois | 60611 | United States | |||
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| Evanston |
| Illinois |
| 60201 |
| United States |
| Detroit | Michigan | 48201 | United States |
| New Brunswick | New Jersey | 08901 | United States |
| Somers Point | New Jersey | 08244 | United States |
| New York | New York | 10032 | United States |
| New York | New York | 10065 | United States |
| Rochester | New York | 14642 | United States |
| Durham | North Carolina | 27710 | United States |
| Cleveland | Ohio | 44195 | United States |
| Pittsburgh | Pennsylvania | 15261 | United States |
| Charlottesville | Virginia | 22908 | United States |
| Athens | 11527 Goudi | Greece |
| Bologna | 40138 | Italy |
| Florence | 50134 | Italy |
| Genova | 16132 | Italy |
| Pisa | 56124 | Italy |
| Roma | 168 | Italy |
| Rome | 161 | Italy |
| Udine | 33100 | Italy |
| Manchester | M239LT | United Kingdom |
| Manchester | MI39WL | United Kingdom |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D016470 | Bacteremia |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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