Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

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I'm Interested

Trial ID: NCT03827694

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

Stanford Investigator(s)

Eligibility


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

Intervention(s):

diagnostic test: Non-Invasive Testing for PIFI

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Angelee Vaid
510-940-3376

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