Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 33
- 主要终点
- Likelihood ratio of the galactomannan assay to return a positive result among subjects determined to have PIFI
研究概览
简要总结
This study will establish a non-invasive diagnostic approach and evaluate clinical outcomes for children at high-risk for pulmonary invasive fungal infection (PIFI).
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
- 120 Days 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females age > 120 days and < 22 years at any participating site
- •Have at least one of the following conditions associated with a known high incidence of IFI: hematopoietic stem cell transplantation (HSCT), aplastic anemia, bone marrow failure, primary or acquired immune deficiency, or malignancy
- •New (last 96 hours) radiographic evidence of at least one of the following: at least one nodular lesion greater than or equal to 5 mm in size, a wedge-shaped and segmental or lobar consolidation, a cavitary lesion, a lesion with a halo sign, a lesion with a reverse halo sign, or a lesion with an air crescent sign
- •Prolonged neutropenia (absolute neutrophil count < 500 cells/µl for a period of ≥ 5 consecutive days) in 30 days prior to and including the day of qualifying chest MRI or CT scan date OR currently receiving systemic therapy for acute or chronic graft-versus-host disease (GVHD) OR presence of neutrophil dysfunction because of underlying acquired or primary immune deficiency (e.g. chronic granulomatous disease) on the date of the qualifying chest MRI or CT scan
- •Subject consent or parental/guardian permission (informed consent) and if appropriate, child assent
排除标准
- •Weight <3 kg, so as to not exceed 3 ml/kg in a single blood draw
- •Previous inclusion in this study
结局指标
主要结局
Likelihood ratio of the galactomannan assay to return a positive result among subjects determined to have PIFI
时间窗: Baseline
Likelihood ratio of galactomannan assay to return a negative result among subjects determined not to have PIFI
时间窗: Baseline
Likelihood ratio of cell-free next generation DNA/RNA sequencing identifying a fungal pathogen to return a positive result among subjects determined to have PIFI
时间窗: Baseline
Likelihood ratio of cell-free next generation DNA/RNA sequencing identifying a fungal pathogen to return a negative result among subjects determined not to have PIFI
时间窗: Baseline
Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a positive result among subjects determined to have PIFI
时间窗: Baseline
Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a negative result among subjects determined not to have PIFI
时间窗: Baseline
Likelihood ratio of molecular RNAseq platform assessing host immune response to return a positive result among subjects determined to have PIFI
时间窗: Baseline
Likelihood ratio of molecular RNAseq platform assessing host immune response to return a negative result among subjects determined not to have PIFI
时间窗: Baseline
次要结局
- Composite outcome score between patients with possible pulmonary invasive fungal infection managed with empirical antifungal therapy versus an invasive diagnostic procedure(49 days)