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

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ClinicalTrials.gov Identifier: NCT02912117
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
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.

Condition or disease
Infection Neutropenia

Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Determining the Etiologic Diagnosis in Febrile Neutropenia Using the Karius Sequencing-based Infectious Disease Diagnostic Assay
Actual Study Start Date : August 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever




Primary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are admitted for fever and neutropenia at the Stanford University Hospital or patients who are admitted for chemotherapy who develop fever and neutropenia at Stanford University Hospital.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912117


Locations
United States, California
Stanford University Hospital
Stanford, California, United States, 94305
Sponsors and Collaborators
Karius, Inc.
Stanford University
Investigators
Principal Investigator: Stanley C Deresinski, MD Stanford University
Principal Investigator: Jose G Montoya, MD Stanford University

Responsible Party: Karius, Inc.
ClinicalTrials.gov Identifier: NCT02912117     History of Changes
Other Study ID Numbers: 004-CL-01
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Neutropenia
Communicable Diseases
Infection
Febrile Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases