Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae

Multi-center, Retrospective Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02420366

Enrollment

257

Registered

2015-04-17

Start date

2014-05-31

Completion date

2015-01-31

Last updated

2018-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pyelonephritis, Bacteremia, Hospital Acquired Bacterial Pneumonia, Urinary Tract Infection, Complicated, Ventilator-associated Bacterial Pneumonia

Brief summary

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)

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

* none

Design outcomes

Primary

Measure	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

Countries

Greece, Italy, United Kingdom, United States

Outcome results