Diagnosis of Bacteremia/Septicemia and Culture Negative Endocarditis by the Karius Sequencing-Based Infectious Disease Diagnostic Assay
NCT ID: NCT02988414
Last Updated: 2018-05-11
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
108 participants
OBSERVATIONAL
2016-07-31
2017-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Staphylococcus aureus Infection
Patients with blood culture confirmed S. aureus bloodstream infections.
No interventions assigned to this group
Gram Negative Infection
Patients with blood culture confirmed Gram Negative bloodstream infecrions
No interventions assigned to this group
Endocarditis
Patients admitted for evaluation of acute endocarditis classified using the Duke Criteria.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. A positive blood culture
3. A suitable residual blood sample collected within 24 hours of the positive blood culture OR
4. A blood sample obtained for the study obtain within 48 hours of the positive blood culture
For Endocarditis Cohort:
1\. All criteria above must be met and patient is admitted to the hospital and evaluated for acute endocarditis classified per the Duke Criteria
Exclusion Criteria
2. Any condition that in the opinion of the treating physician will prevent the subject from completing the study
18 Years
ALL
No
Sponsors
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Duke University
OTHER
Karius, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Vance G Fowler, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Hospital
Durham, North Carolina, United States
Countries
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Other Identifiers
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005-CL-01
Identifier Type: -
Identifier Source: org_study_id
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