Use of NGS Cell-free Pathogen Test for Identification of Low Risk Fever & Neutropenia in Pediatric Patients
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ClinicalTrials.gov Identifier: NCT03530072 |
Recruitment Status : Unknown
Verified August 2019 by Karius, Inc..
Recruitment status was: Enrolling by invitation
First Posted : May 21, 2018
Last Update Posted : August 6, 2019
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Condition or disease | Intervention/treatment |
---|---|
Neutropenia Fever | Diagnostic Test: Karius Test |
- 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.
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 |

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

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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 |
Inclusion Criteria:
1) 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03530072
United States, California | |
Lucille Packard Children's Hopsital | |
Stanford, California, United States, 94304 |
Principal Investigator: | Catherine Aftandillian, MD | Lucille Packard Children's Hospital/Stanford University |
Responsible Party: | Karius, Inc. |
ClinicalTrials.gov Identifier: | NCT03530072 |
Other Study ID Numbers: |
KDP-005 |
First Posted: | May 21, 2018 Key Record Dates |
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 |
Neutropenia Fever Body Temperature Changes Agranulocytosis |
Leukopenia Leukocyte Disorders Hematologic Diseases |