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

Karius

Status: Completed

Conditions: Bacteremia; Septicemia

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02988414

005-CL-01

Details and patient eligibility

About

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

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

108 participants in 3 patient groups

Staphylococcus aureus Infection

Description:

Patients with blood culture confirmed S. aureus bloodstream infections.

Gram Negative Infection

Description:

Patients with blood culture confirmed Gram Negative bloodstream infecrions

Endocarditis

Description:

Patients admitted for evaluation of acute endocarditis classified using the Duke Criteria.