Clinical trial NCT02420366: Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae
Official title: Multi-center, Retrospective Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infection, Complicated
Acute Pyelonephritis
Hospital Acquired Bacterial Pneumonia
Ventilator-associated Bacterial Pneumonia
Bacteremia
Lead sponsor: Melinta Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-17
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with serious CRE infections identified by chart review at up to 20 sites

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of positive CRE infections (specifically cUTI, AP, HABP, VABP, Bacteremia) in a target patient population
timeFrame: 6 month period from September 1, 2013 to March 1, 2014
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
state: Illinois
city: Evanston
country: United States
state: Illinois
city: Detroit
country: United States
state: Michigan
city: New Brunswick
country: United States
state: New Jersey
city: Somers Point
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charlottesville
country: United States
state: Virginia
city: Athens
country: Greece
city: Bologna
country: Italy
city: Firenze
country: Italy
city: Genova
country: Italy
city: Pisa
country: Italy
city: Roma
country: Italy
city: Rome
country: Italy
city: Udine
country: Italy
city: Manchester
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Sponsor GmbH
name: Karen Fusaro
role: STUDY_DIRECTOR
References: