RecruitingNCT03827694
Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections
Sponsor
Arkansas Children's Hospital Research Institute
Enrollment
400 participants
Start Date
Oct 30, 2018
Study Type
OBSERVATIONAL
Conditions
Summary
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
Min Age: 120 DaysMax Age: 21 Years
Inclusion Criteria5
- 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
Exclusion Criteria2
- Weight <3 kg, so as to not exceed 3 ml/kg in a single blood draw
- Previous inclusion in this study
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Interventions
DIAGNOSTIC_TESTNon-Invasive Testing for PIFI
galactomannan assay, fungal PCRs, cell-free next-generation DNA/RNA sequencing, RNAseq
Locations(33)
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NCT03827694