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

Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03530072
• Other study ID #: KDP-005
• Status: Completed
• Start date: May 7, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: February 2023
• Source: Karius, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 31, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fever
• Neutropenia

Intervention

Diagnostic Test:
• Karius Test
Next Generation Sequencing

Locations

Country	Name	City	State
United States	Lucille Packard Children's Hopsital	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Karius, Inc.	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Modeled cost savings	Estimate cost savings for hospital stay with and without Karius results at time of discharge.	1 day of Discharge