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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02988414
Recruitment Status : Completed
First Posted : December 9, 2016
Last Update Posted : May 11, 2018
Duke University
Information provided by (Responsible Party):
Karius, Inc.

Brief 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.

Condition or disease
Bacteremia Septicemia

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Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Diagnosis of Bacteremia/Septicemia by the Karius Sequencing-Based Infectious Disease Diagnostic Assay
Study Start Date : July 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis Sepsis

Staphylococcus aureus Infection
Patients with blood culture confirmed S. aureus bloodstream infections.
Gram Negative Infection
Patients with blood culture confirmed Gram Negative bloodstream infecrions
Patients admitted for evaluation of acute endocarditis classified using the Duke Criteria.

Primary Outcome Measures :
  1. Sensitivity, specificity, positive predictive value, and negative predictive value of the Karius test compared with blood culture in patients with bacteremia/septicemia [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who are at least 18 years of age, have been admitted to Duke University Hospital, and have a positive blood culture.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02988414

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United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Karius, Inc.
Duke University
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Principal Investigator: Vance G Fowler, MD Duke University
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Responsible Party: Karius, Inc. Identifier: NCT02988414    
Other Study ID Numbers: 005-CL-01
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Karius, Inc.:
Additional relevant MeSH terms:
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Communicable Diseases
Disease Attributes
Pathologic Processes
Bacterial Infections
Bacterial Infections and Mycoses
Systemic Inflammatory Response Syndrome