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NCT03827694Recruiting

Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

Arkansas Children's Hospital Research Institute

Start Date

10/30/2018

Completion Date

12/31/2026

Summary

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

Age Range: No minimum to 21 years

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

Interventions

DIAGNOSTIC_TEST

Non-Invasive Testing for PIFI

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Conditions

Pulmonary Invasive Fungal InfectionsPulmonary Invasive Aspergillosis

Locations

Arkansas Children's Research Institute

Little Rock, Arkansas 72202

United States

Rady Children's Hospital, UCSD

La Jolla, California 92093

United States

Children's Hospital of Orange County

Orange, California 92868

United States

Lucile Packard Children's Hospital, Stanford University

Palo Alto, California 94305

United States

University of California San Francisco, Benioff Children's Hospital

San Francisco, California 94143

United States

Yale University

New Haven, Connecticut 06520

United States

Children's National Hospital

Washington D.C., District of Columbia 20010-2916

United States

All Children's Research Institute

St. Petersburg, Florida 33701

United States

Emory University-Children's Healthcare of Atlanta (CHOA)

Atlanta, Georgia 30322

United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois 60611

United States

University of Chicago Medicine, Comer Children's

Chicago, Illinois 60637

United States

Indiana University School of Medicine

Indianapolis, Indiana 46202

United States

Boston Children's Hospital

Boston, Massachusetts 02241

United States

University of Minnesota Medical School

Minneapolis, Minnesota 55455

United States

Children's Minnesota

Saint Paul, Minnesota 55102

United States

Children's Mercy

Kansas City, Missouri 64108

United States

The Washington University

St Louis, Missouri 63110

United States

Children's Omaha

Omaha, Nebraska 68114

United States

Weil Cornell Medical College

New York, New York 10021

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Nationwide Children's Hospital

Columbus, Ohio 43205-2664

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19146

United States

St. Jude Children's Research Hospital

Memphis, Tennessee 38105

United States

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee 37232

United States

Ascension Seton Medical Center

Austin, Texas 78705

United States

University of Texas Southwest Medical Center (UTSW)

Dallas, Texas 75390

United States

MD Anderson

Houston, Texas 77030

United States

Seattle Children's Research Institute

Seattle, Washington 98105

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

The Hospital for Sick Children

Toronto, Ontario M5G 1E8

Canada