About this trial
This study will establish a non-invasive diagnostic approach and evaluate clinical outcomes for children at high-risk for pulmonary invasive fungal infection (PIFI).
Eligibility criteria
Qualifiers
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
Disqualifiers
Weight <3 kg, so as to not exceed 3 ml/kg in a single blood draw
Previous inclusion in this study
Trial design
Treatments tested in this trial
- Non-Invasive Testing for PIFI
Treatment groups
Sponsors and collaborators
Arkansas Children's Hospital Research Institute
Lead sponsor
Children's Hospital of Philadelphia
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator