Use of NGS Cell-free Pathogen Test for Identification of Low Risk Fever & Neutropenia in Pediatric Patients
Using Next Gen Sequencing to Identify Pediatric Patients With Febrile Neutropenia at Low Risk for Complications: A Pilot Study
1 other identifier
observational
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2018
CompletedStudy Start
First participant enrolled
May 7, 2018
CompletedFirst Posted
Study publicly available on registry
May 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2019
CompletedFebruary 10, 2023
February 1, 2023
1.2 years
May 7, 2018
February 8, 2023
Conditions
Outcome Measures
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
1 day of Discharge
Secondary Outcomes (1)
Modeled cost savings
1 day of Discharge
Study Arms (1)
Cases
Subjects with Fever and Neutropenia
Interventions
Eligibility Criteria
Children being admitted for inpatient treatment with fever and neutropenia.
You may qualify if:
- \) Pediatric oncology patients, aged 1-22, treated at Lucile Packard Children's Hospital (LPCH)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karius, Inc.lead
- Stanford Universitycollaborator
Study Sites (1)
Lucille Packard Children's Hopsital
Stanford, California, 94304, United States
Biospecimen
Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine Aftandillian, MD
Lucille Packard Children's Hospital/Stanford University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2018
First Posted
May 21, 2018
Study Start
May 7, 2018
Primary Completion
August 1, 2019
Study Completion
October 31, 2019
Last Updated
February 10, 2023
Record last verified: 2023-02