Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae
NCT ID: NCT02420366
Last Updated: 2018-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
257 participants
OBSERVATIONAL
2014-05-31
2015-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
INDUSTRY
Responsible Party
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Principal Investigators
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Karen Fusaro
Role: STUDY_DIRECTOR
Sponsor GmbH
Locations
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Chicago, Illinois, United States
Evanston, Illinois, United States
Detroit, Michigan, United States
New Brunswick, New Jersey, United States
Somers Point, New Jersey, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Pittsburgh, Pennsylvania, United States
Charlottesville, Virginia, United States
Athens, , Greece
Bologna, , Italy
Florence, , Italy
Genova, , Italy
Pisa, , Italy
Roma, , Italy
Rome, , Italy
Udine, , Italy
Manchester, , United Kingdom
Manchester, , United Kingdom
Countries
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Other Identifiers
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Rempex 506 NH
Identifier Type: -
Identifier Source: org_study_id
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