Diagnosis of Bacteremia/Septicemia and Culture Negative Endocarditis by the Karius Sequencing-Based Infectious Disease Diagnostic Assay



Status:Completed
Conditions:Infectious Disease, Infectious Disease, Hospital, Hematology
Therapuetic Areas:Hematology, Immunology / Infectious Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:5/13/2018
Start Date:July 2016
End Date:April 2017

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Trial Summary
Trial Overview
Inclusion Criteria

Diagnosis of Bacteremia/Septicemia by the Karius Sequencing-Based Infectious Disease Diagnostic Assay

Prospective study at Duke University Hospital comparing the Karius Infectious Disease
Diagnostic Sequencing Assay to blood culture results in admitted patients with
bacteremia/septicemia.


Inclusion Criteria:

1. 18 years or older

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:

1. Inability to understand instructions and comply with study-related procedures

2. Any condition that in the opinion of the treating physician will prevent the subject
from completing the study
We found this trial at
1
site
Duke University Hospital
Durham, North Carolina 27705
?
mi
from
Durham, NC
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