Using Next Gen Sequencing to Identify Pediatric Patients With Febrile Neutropenia at Low Risk for Complications: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Karius, Inc.
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Modeled sensitivity and specificity
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric oncology patients, aged 1-22, treated at Lucile Packard Children's Hospital (LPCH)
排除标准
- •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.
结局指标
主要结局
Modeled sensitivity and specificity
时间窗: 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
次要结局
- Modeled cost savings(1 day of Discharge)