Bacteremia Clinical Trial
Official title:
Diagnosis of Bacteremia/Septicemia by the Karius Sequencing-Based Infectious Disease Diagnostic Assay
NCT number | NCT02988414 |
Other study ID # | 005-CL-01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | April 2017 |
Verified date | April 2017 |
Source | Karius, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Prospective study at Duke University Hospital comparing the Karius Infectious Disease Diagnostic Sequencing Assay to blood culture results in admitted patients with bacteremia/septicemia.
Status | Completed |
Enrollment | 108 |
Est. completion date | April 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Hospital | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Karius, Inc. | Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity, specificity, positive predictive value, and negative predictive value of the Karius test compared with blood culture in patients with bacteremia/septicemia | 12 months |
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