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

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ClinicalTrials.gov Identifier: NCT02988414
Recruitment Status : Completed
First Posted : December 9, 2016
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
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

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

Group/Cohort
Staphylococcus aureus Infection
Patients with blood culture confirmed S. aureus bloodstream infections.
Gram Negative Infection
Patients with blood culture confirmed Gram Negative bloodstream infecrions
Endocarditis
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
Plasma


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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02988414


Locations
United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Karius, Inc.
Duke University
Investigators
Principal Investigator: Vance G Fowler, MD Duke University

Responsible Party: Karius, Inc.
ClinicalTrials.gov Identifier: NCT02988414     History of Changes
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.:
Sepsis
Infection
Culture
Sequencing
Non-invasive
NGS

Additional relevant MeSH terms:
Bacteremia
Communicable Diseases
Infection
Sepsis
Toxemia
Bacterial Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes