Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

Status:	Recruiting
Conditions:	Infectious Disease, Pulmonary
Therapuetic Areas:	Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	Any - 21
Updated:	2/8/2019
Start Date:	October 30, 2018
End Date:	December 31, 2022
Contact:	PFN Central Coordinator
Email:	PFNClinical@duke.edu
Phone:	919-668-4847

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

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 IMI: hematopoietic stem cell transplantation (HSCT), aplastic anemia, or
hematologic malignancy

- New (last 96 hours) radiographic evidence showing at least one pulmonary nodule ≥ 1 cm
in diameter

- Prolonged neutropenia (absolute neutrophil count < 500 cells/µl for a period of ≥ 5
consecutive days) in 30 days prior to qualifying chest MRI or CT scan date OR
currently receiving systemic therapy for acute or chronic graft-versus-host disease
(GVHD) 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:

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

- Previous inclusion in this study

We found this trial at

sites

Emory University

201 Dowman Dr
Atlanta, Georgia 30303

(404) 727-6123