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Completed

NCT Number: NCT02912117

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

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.

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Key information

Conditions

Infection Agranulocytosis Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Infections Leukocyte Disorders Leukopenia Neutropenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University Hospital

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sensitivity, specificity, positive predictive value, and negative predictive value of the Karius Infectious Disease Diagnostic Sequencing Assay compared with standard clinical diagnosis

    Time frame: 12 Months

Sponsors and collaborators

Lead sponsor

Karius, Inc.

Industry

Collaborators

  • Stanford University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 23, 2016
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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