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OpenTrials
Completed

NCT Number: NCT03530072

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

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.

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Key information

Conditions

Neutropenia Agranulocytosis Body Temperature Changes Cytopenia Fever Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 year–22 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lucille Packard Children's Hopsital

Stanford, California, 94304, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Karius Test

Diagnostic Test

Next Generation Sequencing

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Karius, Inc.

Industry

Collaborators

  • Stanford University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 21, 2018
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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