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NCT02912117 Clinical Trial

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

Infection Clinical Trial

Official title:
Determining the Etiologic Diagnosis in Febrile Neutropenia Using the Karius Sequencing-based Infectious Disease Diagnostic Assay

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02912117
Other study ID # 004-CL-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2016
Est. completion date May 2018

Study information
Verified date March 2018
Source Karius, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 57
Est. completion date May 2018
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Stanford University Hospital Stanford California

Sponsors (2)
Lead Sponsor Collaborator
Karius, Inc. Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity, specificity, positive predictive value, and negative predictive value of the Karius Infectious Disease Diagnostic Sequencing Assay compared with standard clinical diagnosis 12 Months
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