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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02988414

Enrollment

108

Registered

2016-12-09

Start date

2016-07-31

Completion date

2017-04-30

Last updated

2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacteremia, Septicemia

Keywords

Sepsis, Infection, Culture, Sequencing, Non-invasive, NGS

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Sensitivity, specificity, positive predictive value, and negative predictive value of the Karius test compared with blood culture in patients with bacteremia/septicemia	12 months

Countries

United States

Outcome results