Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections
Trial ID or NCT#
NCT03827694
Status
RECRUITING
Purpose
This study will establish a non-invasive diagnostic approach and evaluate clinical outcomes for children at high-risk for pulmonary invasive fungal infection (PIFI).
Official Title
Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections
Eligibility Criteria
Ages Eligible for Study: 120 Days to 21 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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:
- - Weight <3 kg, so as to not exceed 3 ml/kg in a single blood draw - Previous inclusion in this study
Investigator(s)
Catherine Aftandilian
Contact us to find out if this trial is right for you.
Contact
Angelee Vaid
510-940-3376
View on ClinicalTrials.gov
