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

NCT ID: NCT03530072

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-07
• Study Completion Date: 2019-10-31

Brief 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.

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.

Conditions

Neutropenia; Fever

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cases

Subjects with Fever and Neutropenia

Karius Test

Intervention Type: DIAGNOSTIC_TEST

Next Generation Sequencing

Interventions

Karius Test

Next Generation Sequencing

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

Karius, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Aftandillian, MD

Role: PRINCIPAL_INVESTIGATOR

Lucille Packard Children's Hospital/Stanford University

Locations

Lucille Packard Children's Hopsital

Stanford, California, United States

Countries

United States

Other Identifiers

KDP-005

Identifier Type: -

Identifier Source: org_study_id