NCT02912117

Completed

Determining the Etiology of Febrile Neutropenia Using the Ka...

Karius, Inc.Source

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Other study identifiers

Sponsor study identifier

004-CL-01

Study Type

observational

Actual enrollment (reported)

57

Locations

1 country

Sites

1

Timeline

Study Start

August 2016

Actual (reported)

Primary Completion

February 2018

Actual (reported)

Study Completion

May 2018

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 57 participants
Study completion date: May 2018
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2016
Actual (reported)
First Submitted
September 19, 2016
Actual (reported)
First Posted
September 23, 2016
Actual (reported)
Primary Completion
February 2018
Actual (reported)
Study Completion
May 2018
Actual (reported)

Last Updated: May 11, 2018
Status Verified: March 2018
Last Update Submitted: May 7, 2018

Conditions

Infection Neutropenia

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

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

years of age

Sponsors & Collaborators

Stanford University
Othercollaborator
Karius, Inc.
Industrylead

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

Retention: SAMPLES WITH DNA

Plasma

MeSH Terms

Conditions

InfectionsNeutropenia

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

Stanley C Deresinski, MD
Stanford University
PRINCIPAL INVESTIGATOR
Jose G Montoya, MD
Stanford University
PRINCIPAL INVESTIGATOR

Enrollment

57 participants (actual enrollment reported by the registry).

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 2016

Actual (reported)

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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.

Primary Completion

February 2018

Actual (reported)

Study Completion

May 2018

Actual (reported)

Last Updated

May 11, 2018

Record last verified: 2018-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02912117
Data provider: ClinicalTrials.gov
Source updated: 2018-05-11
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:37 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations