Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

Recruiting now

Conditions studied: Pulmonary Invasive Fungal Infections, Pulmonary Invasive Aspergillosis

In brief

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

Key facts

Study ID

NCT03827694

Run by

Arkansas Children's Hospital Research Institute

People needed

400

Starts

2018-10-30

Expected to finish

2026-12-31

Last updated by the study team

2024-09-25

Who can join

Age: 0 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Weight <3 kg, so as to not exceed 3 ml/kg in a single blood draw
• Previous inclusion in this study

Where it is running

• The Hospital for Sick Children — Toronto, Ontario, Canada (enrolling)
• Rady Children's Hospital, UCSD — La Jolla, California, United States (enrolling)
• Children's Hospital of Orange County — Orange, California, United States (enrolling)
• Lucile Packard Children's Hospital, Stanford University — Palo Alto, California, United States (enrolling)
• University of Texas Southwest Medical Center (UTSW) — Dallas, Texas, United States (enrolling)
• MD Anderson — Houston, Texas, United States (enrolling)
• Seattle Children's Research Institute — Seattle, Washington, United States (enrolling)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
• Arkansas Children's Research Institute — Little Rock, Arkansas, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• Children's National Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Emory University-Children's Healthcare of Atlanta (CHOA) — Atlanta, Georgia, United States (enrolling)
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
• University of Chicago Medicine, Comer Children's — Chicago, Illinois, United States (enrolling)
• Indiana University School of Medicine — Indianapolis, Indiana, United States (enrolling)
• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• Children's Minnesota — Saint Paul, Minnesota, United States (enrolling)
• Children's Mercy — Kansas City, Missouri, United States (enrolling)
• The Washington University — St Louis, Missouri, United States (enrolling)
• Children's Omaha — Omaha, Nebraska, United States (enrolling)
• Weil Cornell Medical College — New York, New York, United States (enrolling)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
• Oregon Health and Science University — Portland, Oregon, United States (enrolling)
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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