Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections (DOMINIC)

Arkansas Children's Hospital Research Institute

Status

Enrolling

Conditions

Pulmonary Invasive Fungal Infections

Pulmonary Invasive Aspergillosis

Treatments

Diagnostic Test: Non-Invasive Testing for PIFI

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT03827694

R01AI139032 (U.S. NIH Grant/Contract)

Pro00094558

Details and patient eligibility

About

This study will establish a non-invasive diagnostic approach and evaluate clinical outcomes for children at high-risk for pulmonary invasive fungal infection (PIFI).

Enrollment

400 estimated patients

Sex

All

Ages

120 days to 21 years old

Volunteers

No Healthy Volunteers

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 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 criteria