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
1 other identifier
observational
57
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 19, 2016
CompletedFirst Posted
Study publicly available on registry
September 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedMay 11, 2018
March 1, 2018
1.5 years
September 19, 2016
May 7, 2018
Conditions
Outcome Measures
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
12 Months
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karius, Inc.lead
- Stanford Universitycollaborator
Study Sites (1)
Stanford University Hospital
Stanford, California, 94305, United States
Related Publications (1)
Benamu E, Gajurel K, Anderson JN, Lieb T, Gomez CA, Seng H, Aquino R, Hollemon D, Hong DK, Blauwkamp TA, Kertesz M, Blair L, Bollyky PL, Medeiros BC, Coutre S, Zompi S, Montoya JG, Deresinski S. Plasma Microbial Cell-free DNA Next-generation Sequencing in the Diagnosis and Management of Febrile Neutropenia. Clin Infect Dis. 2022 May 3;74(9):1659-1668. doi: 10.1093/cid/ciab324.
PMID: 33870413DERIVED
Biospecimen
Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stanley C Deresinski, MD
Stanford University
- PRINCIPAL INVESTIGATOR
Jose G Montoya, MD
Stanford University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2016
First Posted
September 23, 2016
Study Start
August 1, 2016
Primary Completion
February 1, 2018
Study Completion
May 1, 2018
Last Updated
May 11, 2018
Record last verified: 2018-03