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NCT03530072 · ClinicalTrials.gov registry record
Use of NGS Cell-free Pathogen Test for Identification of Low Risk Fever & Neutropenia in Pediatric Patients
A clinical trial, sponsored by Karius.
- Completed
- Registry status
- 15
- Enrollment target
NCT03530072: Completed study, sponsored by Karius.
NCT03530072 is a clinical trial that has completed, run by Karius. The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03530072 has completed, sponsored by Karius.
- COMPLETED
- Registry status
- 15 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DIAGNOSTIC_TEST Karius Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-05-07 |
| Est. Completion | 2019-10-31 |
What the finished NCT03530072 record still lists
NCT03530072 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 15 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Karius Test is the first listed.
NCT03530072 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03530072 about?
NCT03530072 is a clinical study titled "Use of NGS Cell-free Pathogen Test for Identification of Low Risk Fever & Neutropenia in Pediatric Patients". 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 admiss...
What is the current status of trial NCT03530072?
This trial is currently completed. The enrollment target is 15 participants. The study started on 2018-05-07. Estimated completion is 2019-10-31.
What interventions are being tested in trial NCT03530072?
The interventions under investigation include: Karius Test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03530072?
This trial is sponsored by Karius, which has 7 total clinical trials registered on ClinicalTrials.gov.
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