Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age120-21
SponsorArkansas Children's Hospital Research Institute

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

400 Participants
are divided into 1 treatment group

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