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CompletedNCT03530072Updated Feb 10, 2023

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

An observational study in Neutropenia and Fever, sponsored by Karius, Inc.. Completed at 1 site in United States. Open to participants aged 1 Year to 22 Years. Per ClinicalTrials.gov, last updated 2023-02-10.

Sponsored by Karius, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
1 Year to 22 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Neutropenia
  • Fever

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03

In context

Neutropenia

396 studies on the registry are indexed under Neutropenia; 57 are open to participants now.

This study's enrollment of 15 is below the median of 175 across 96 observational studies indexed under Neutropenia.

Browse Neutropenia studies →

Lead sponsor

Karius, Inc. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 22 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children being admitted for inpatient treatment with fever and neutropenia.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Cases

    Subjects with Fever and Neutropenia

    Diagnostic Test: Karius Test

Interventions

  • Diagnostic testKarius Test

    Next Generation Sequencing

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 day of Discharge

Secondary outcomes

  1. Modeled cost savings

    Estimate cost savings for hospital stay with and without Karius results at time of discharge.

    Time frame: 1 day of Discharge

07

Study locations

1 site
  • Lucille Packard Children's Hopsital
    Stanford, California 94304, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03530072
Lead sponsor
Karius, Inc.
Collaborators
Stanford University
Responsible party
Sponsor
First posted
May 21, 2018
Start date
May 7, 2018
Primary completion
Aug 1, 2019
Completion
Oct 31, 2019
Last update
Feb 10, 2023

Study contacts

Catherine Aftandillian, MD
principal investigator · Lucille Packard Children's Hospital/Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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