Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

Inclusion Criteria:

• 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 incidenceof IFI: hematopoietic stem cell transplantation (HSCT), aplastic anemia, bone marrowfailure, primary or acquired immune deficiency, or malignancy

• New (last 96 hours) radiographic evidence of at least one of the following: at leastone nodular lesion greater than or equal to 5 mm in size, a wedge-shaped andsegmental or lobar consolidation, a cavitary lesion, a lesion with a halo sign, alesion 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 ≥ 5consecutive days) in 30 days prior to and including the day of qualifying chest MRIor CT scan date OR currently receiving systemic therapy for acute or chronicgraft-versus-host disease (GVHD) OR presence of neutrophil dysfunction because ofunderlying acquired or primary immune deficiency (e.g. chronic granulomatousdisease) on the date of the qualifying chest MRI or CT scan

• Subject consent or parental/guardian permission (informed consent) and ifappropriate, child assent

Exclusion Criteria:

• Weight <3 kg, so as to not exceed 3 ml/kg in a single blood draw

• Previous inclusion in this study