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

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

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.

Study Overview

• Status: Completed
• Conditions: Neutropenia; Fever
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Lucille Packard Children's Hopsital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 22 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children being admitted for inpatient treatment with fever and neutropenia.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; Subjects with Fever and Neutropenia	Diagnostic test: Karius Test; Next Generation Sequencing

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karius, Inc.
• Collaborators: Stanford University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 7, 2018
• Primary Completion (ACTUAL): August 1, 2019
• Study Completion (ACTUAL): October 31, 2019

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: May 18, 2018
• First Posted (ACTUAL): May 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Body Temperature Changes; Neutropenia; Fever
• Other Study ID Numbers: KDP-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No