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

Completed

• Conditions: Septicemia; Bacteremia

• Registration Number: NCT02988414
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-12-07
• Study First Submitted QC: 2016-12-07
• Study First Posted: 2016-12-09
• Status Verified: 2017-04
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2018-05-07
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States