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

NCT ID: NCT02912117

Last Updated: 2018-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infection Neutropenia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role collaborator

Karius, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stanley C Deresinski, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Jose G Montoya, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University Hospital

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33870413 (View on PubMed)

Other Identifiers

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004-CL-01

Identifier Type: -

Identifier Source: org_study_id

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