Use of NGS Cell-free Pathogen Test for Identification of Low Risk Fever & Neutropenia in Pediatric Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|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|
|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|
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
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|