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Use of NGS Cell-free Pathogen Test for Identification of Low Risk Fever & Neutropenia in Pediatric Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03530072
Recruitment Status : Enrolling by invitation
First Posted : May 21, 2018
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Karius, Inc.

Study Description
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Brief Summary:
Febrile neutropenia is a common complication in pediatric oncology patients. Standard of care requires admission of all patients for intravenous antibiotics until cultures are negative, patients are afebrile and there are signs of bone marrow recovery. This often results in prolonged hospital admissions with significant financial costs, decreased quality of life and potential secondary infections. More recent data suggests it may be possible to identify a "low risk" group that can be discharged prior to signs of bone marrow recovery. At this time, researchers have been unable to identify a model that is safe for early discharge across institutions.

Condition or disease Intervention/treatment
Neutropenia Fever Diagnostic Test: Karius Test

Detailed Description:
  1. Conduct a pilot study to determine the feasibility of using the Karius Assay to risk stratify pediatric oncology patients admitted with febrile neutropenia. This will provide preliminary data for a larger study which would randomize patients to early discharge vs. usual care.
  2. Evaluate the Klaasen and SPOG clinical decision rules with and without the Karius Assay to predict patients at low risk for adverse infectious outcomes during admission. Adverse infectious outcome will be defined as: positive blood or urine culture, radiographic evidence of infection, admission to the intensive care unit or death.
  3. Model potential cost savings of early discharge for patients deemed low risk for an adverse infectious outcome.
Study Design
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Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Using Next Gen Sequencing to Identify Pediatric Patients With Febrile Neutropenia at Low Risk for Complications: A Pilot Study
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Groups and Cohorts
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Group/Cohort Intervention/treatment
Cases
Subjects with Fever and Neutropenia
 Diagnostic Test: Karius Test
Next Generation Sequencing


Outcome Measures
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Primary Outcome Measures :
  1. Modeled sensitivity and specificity [ Time Frame: 1 day of Discharge ]
    Sensitivity, specificity, PPV, NPV of Klassen and SPOG clinical decision rules with and without incorporation of Karius test for prediction of patients at low risk for infectious outcomes during hospital admission. Assessed at time of Discharge


Secondary Outcome Measures :
  1. Modeled cost savings [ Time Frame: 1 day of Discharge ]
    Estimate cost savings for hospital stay with and without Karius results at time of discharge.


Biospecimen Retention:   Samples With DNA
Plasma

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children being admitted for inpatient treatment with fever and neutropenia.
Criteria

Inclusion Criteria:

1) Pediatric oncology patients, aged 1-22, treated at Lucile Packard Children's Hospital (LPCH)

Exclusion Criteria:

  1. Relapsed disease
  2. Acute lymphoblastic leukemia during induction
  3. Acute myeloid leukemia during any phase of treatment
  4. Philadelphia-chromosome positive ALL
  5. Down syndrome
  6. Patients who have received an allogeneic stem cell transplant.
Contacts and Locations
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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): NCT03530072


Locations
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United States, California
Lucille Packard Children's Hopsital
Stanford, California, United States, 94304
Sponsors and Collaborators
Karius, Inc.
Stanford University
Investigators
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Principal Investigator: Catherine Aftandillian, MD Lucille Packard Children's Hospital/Stanford University
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Karius, Inc.
ClinicalTrials.gov Identifier: NCT03530072    
Other Study ID Numbers: KDP-005
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neutropenia
Fever
Body Temperature Changes
Signs and Symptoms
 Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases