Evaluation of NGS for Detection and Follow-up of Fungal Pathogens in Immunocompromised Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Karius, Inc.
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of positivity for fungal specific pathogens on NGS analysis
研究概览
简要总结
The Sponsor hypothesize that Next-generation Sequencing (NGS) can identify fungal pathogens, is more accurate than other noninvasive options and can report fungal genomic load.
详细描述
The Sponsor aims to describe the incidence of positivity for fungal specific pathogens on NGS analysis in a high-risk immunocompromised pediatric population.
Secondarily, the Sponsor will correlate results of the NGS analysis to other approved fungal tests if performed at the discretion of the treating provider (e.g. blood culture results, radiographic findings, biopsy results, bronchoalveolar lavage findings, galactomannan results or b-D-glucan (BG) results as evaluated via FDA-approved "Fungitell" assay). The Sponsor will use these other fungal tests, in addition to clinical criterion, to classify subjects as having possible, probable and proven IFD according to established criteria, and compare these categories against results from NGS analysis.
Lastly, to quantitatively evaluate follow-up test results to determine fungal DNA genomic load in subjects with positive results.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prolonged FN (≥96 hours) despite broad-spectrum antibiotic therapy with anticipated delayed neutrophil recovery
- •Any findings that trigger the primary team to consider new fungal infection in a given inpatient, such as abnormal imaging results, recrudescent fevers in the setting of neutropenia or characteristic skin rashes
排除标准
- •Those without concern for fungal infection or those currently being treated for a presumed or documented fungal infection will not be recruited for this study
结局指标
主要结局
Incidence of positivity for fungal specific pathogens on NGS analysis
时间窗: 7 months
We aim to describe the incidence of positivity for fungal specific pathogens on NGS analysis in a high-risk immunocompromised pediatric population.
次要结局
未报告次要终点