Infection Clinical Trial
Official title:
Determining the Etiologic Diagnosis in Febrile Neutropenia Using the Karius Sequencing-based Infectious Disease Diagnostic Assay
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 |
Verified date | March 2018 |
Source | Karius, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University Hospital | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Karius, Inc. | Stanford University |
United States,
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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