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NCT02988414 Clinical Trial

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

Bacteremia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date April 2017
Source Karius, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Duke University Hospital Durham North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Karius, Inc. Duke University

Country where clinical trial is conducted

United States, 

Outcome
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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