Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae
| Status: | Completed |
|---|---|
| Conditions: | Pneumonia, Infectious Disease, Infectious Disease, Nephrology, Hematology, Urology |
| Therapuetic Areas: | Hematology, Immunology / Infectious Diseases, Nephrology / Urology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/4/2018 |
| Start Date: | May 2014 |
| End Date: | January 2015 |
Multi-center, Retrospective Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae
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)
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.
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.
Inclusion Criteria:
- Male or female ≥18 years of age.
- Carbapenem resistant Enterobacteriaceae (CRE) must be identified in the urine, blood
or respiratory tract samples submitted for culture in the setting of cUTI or AP, HABP,
VABP, and/or bacteremia.
- Diagnosis with either cUTI or AP, HABP, VABP, and/or bacteremia.
Exclusion Criteria:
We found this trial at
12
sites
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