Determining the Etiology of Febrile Neutropenia Using the Karius Sequencing-based Infectious Disease Diagnostic Assay

Completed

• Conditions: Infection; Neutropenia

• Registration Number: NCT02912117
• Lead Sponsor: Karius, Inc.

Brief Summary

Prospective, observational study at Stanford University Hospital comparing the Karius Infectious Disease Diagnostic Sequencing Assay to the Final Microbiologic Diagnosis in Patients with Fever and Neutropenia.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-09-19
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-23
• Primary Completion: 2018-02
• Status Verified: 2018-03
• Study Completion: 2018-05
• Last Update Submitted: 2018-05-07
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• 18 years of age
• Are or will be admitted to Stanford University Hospital for fever and neutropenia
• Neutropenia - an absolute neutrophil count of <500 per cubic mm
• Documented fever or report of fever ≥38.3 or ≥38.0 on two episodes separated by at least one hour, resulting in hospitalization for febrile neutropenia

Exclusion Criteria

• 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

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 Infectious Disease Diagnostic Sequencing Assay compared with standard clinical diagnosis	12 Months

Trial Locations

Locations (1)

Stanford University Hospital; 🇺🇸 Stanford, California, United States