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

• ClinicalTrials.gov Identifier: NCT03530072
• Recruitment Status: Unknown
• First Posted: May 21, 2018
• Last Update Posted: August 6, 2019
• Sponsor: Karius, Inc.
• Collaborator: Stanford University
• Information provided by (Responsible Party): Karius, Inc.

Study Description

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.

Condition or disease	Intervention/treatment
Neutropenia; Fever	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 Design

• Study Type: Observational
• Actual Enrollment: 57 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Using Next Gen Sequencing to Identify Pediatric Patients With Febrile Neutropenia at Low Risk for Complications: A Pilot Study
• Actual Study Start Date: May 7, 2018
• Estimated Primary Completion Date: August 1, 2019
• Estimated Study Completion Date: October 31, 2020

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Biospecimen Retention:   Samples With DNA

Plasma

Eligibility Criteria

• Ages Eligible for Study: 1 Year to 22 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Children being admitted for inpatient treatment with fever and neutropenia.

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.

Contacts and Locations

Locations

United States, California

Lucille Packard Children's Hopsital

Stanford, California, United States, 94304

Sponsors and Collaborators

Karius, Inc.

Stanford University

Investigators

• Principal Investigator: Catherine Aftandillian, MD; Lucille Packard Children's Hospital/Stanford University

More Information

• Responsible Party: Karius, Inc.
• ClinicalTrials.gov Identifier: NCT03530072
• Other Study ID Numbers: KDP-005
• First Posted: May 21, 2018
• Last Update Posted: August 6, 2019
• Last Verified: August 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neutropenia; Fever; Body Temperature Changes; Agranulocytosis; Leukopenia; Leukocyte Disorders; Hematologic Diseases