Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

Description

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

Conditions

Pulmonary Invasive Fungal Infections, Pulmonary Invasive Aspergillosis

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Study Overview

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Study Details

Study overview

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

Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

Condition
Pulmonary Invasive Fungal Infections
Intervention / Treatment

-

Contacts and Locations

Little Rock

Arkansas Children's Research Institute, Little Rock, Arkansas, United States, 72202

La Jolla

Rady Children's Hospital, UCSD, La Jolla, California, United States, 92093

Orange

Children's Hospital of Orange County, Orange, California, United States, 92868

Palo Alto

Lucile Packard Children's Hospital, Stanford University, Palo Alto, California, United States, 94305

San Francisco

University of California San Francisco, Benioff Children's Hospital, San Francisco, California, United States, 94143

New Haven

Yale University, New Haven, Connecticut, United States, 06520

Washington

Children's National Hospital, Washington, District of Columbia, United States, 20010-2916

Saint Petersburg

All Children's Research Institute, Saint Petersburg, Florida, United States, 33701

Atlanta

Emory University-Children's Healthcare of Atlanta (CHOA), Atlanta, Georgia, United States, 30322

Chicago

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States, 60611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

120 Days to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Arkansas Children's Hospital Research Institute,

William Steinbach, PRINCIPAL_INVESTIGATOR, University of Arkansas

Brian Fisher, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

Study Record Dates

2026-12-31