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

NCT02988414 | Completed

• 1 other identifier: 005-CL-01
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacteremia; Septicemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Sensitivity, specificity, positive predictive value, and negative predictive value of the Karius test compared with blood culture in patients with bacteremia/septicemia

  12 months

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years or older
• A positive blood culture
• A suitable residual blood sample collected within 24 hours of the positive blood culture OR
• A blood sample obtained for the study obtain within 48 hours of the positive blood culture
• For Endocarditis Cohort:
• \. All criteria above must be met and patient is admitted to the hospital and evaluated for acute endocarditis classified per the Duke Criteria

You may not qualify if:

• Inability to understand instructions and comply with study-related procedures
• Any condition that in the opinion of the treating physician will prevent the subject from completing the study

Sponsors & Collaborators

• Karius, Inc.: lead
• Duke University: collaborator

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma

MeSH Terms

Conditions

Bacteremia; Sepsis; Infections

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vance G Fowler, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 9, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 11, 2018

Record last verified: 2017-04

Locations

US (1)