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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02912117

Enrollment

Registered

2016-09-23

Start date

2016-08-31

Completion date

2018-05-31

Last updated

2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Neutropenia

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results