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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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. Model potential cost savings of early discharge for patients deemed low risk for an adverse infectious outcome.

Official Title
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Using Next Gen Sequencing to Identify Pediatric Patients With Febrile Neutropenia at Low Risk for Complications: A Pilot Study

Conditions
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Neutropenia, Fever

Intervention / Treatment
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* Diagnostic Test: Karius Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Pediatric oncology patients, aged 1-22, treated at Lucile Packard Children's Hospital (LPCH) Exclusion Criteria: Relapsed disease Acute lymphoblastic leukemia during induction Acute myeloid leukemia during any phase of treatment Philadelphia-chromosome positive ALL Down syndrome Patients who have received an allogeneic stem cell transplant.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Subjects with Fever and Neutropenia | Diagnostic Test: Karius Test<br>* Next Generation Sequencing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modeled sensitivity and specificity | 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 | 1 day of Discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modeled cost savings | Estimate cost savings for hospital stay with and without Karius results at time of discharge. | 1 day of Discharge |