Recruiting

Observational Study

Sponsor:

Arkansas Children's Hospital Research Institute

Code:

NCT03827694

Conditions

Pulmonary Invasive Fungal Infections

Pulmonary Invasive Aspergillosis

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Non-Invasive Testing for PIFI

Study Details

Brief 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).

Conditions

Pulmonary Invasive Fungal Infections

Pulmonary Invasive Aspergillosis

Study ID

NCT03827694

Start date

Oct 30, 2018

Status verified date

Sep, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with possible PIFI

Interventions

Non-Invasive Testing for PIFI

galactomannan assay, fungal PCRs, cell-free next-generation DNA/RNA sequencing, RNAseq

Primary outcome measure

  • Likelihood ratio of the galactomannan assay to return a positive result among subjects determined to have PIFI [ Time Frame: Baseline ]
  • Likelihood ratio of galactomannan assay to return a negative result among subjects determined not to have PIFI [ Time Frame: Baseline ]
  • Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a positive result among subjects determined to have PIFI [ Time Frame: Baseline ]
  • Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a negative result among subjects determined not to have PIFI [ Time Frame: Baseline ]
  • Likelihood ratio of cell-free next generation DNA/RNA sequencing identifying a fungal pathogen to return a positive result among subjects determined to have PIFI [ Time Frame: Baseline ]
  • Likelihood ratio of cell-free next generation DNA/RNA sequencing identifying a fungal pathogen to return a negative result among subjects determined not to have PIFI [ Time Frame: Baseline ]
  • Likelihood ratio of molecular RNAseq platform assessing host immune response to return a positive result among subjects determined to have PIFI [ Time Frame: Baseline ]
  • Likelihood ratio of molecular RNAseq platform assessing host immune response to return a negative result among subjects determined not to have PIFI [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

PFN Central Coordinator

501-364-3057PFNClinical@uams.edu

Locations

Arkansas Children's Research Institute

Recruiting

Little Rock, Arkansas, United States, 72202

Rady Children's Hospital, UCSD

Recruiting

La Jolla, California, United States, 92093

Children's Hospital of Orange County

Recruiting

Orange, California, United States, 92868

Lucile Packard Children's Hospital, Stanford University

Recruiting

Palo Alto, California, United States, 94305

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Children's National Hospital

Recruiting

Washington, District of Columbia, United States, 20010-2916

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

Recruiting

Atlanta, Georgia, United States, 30322

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

Recruiting

Chicago, Illinois, United States, 60611

University of Chicago Medicine, Comer Children's

Recruiting

Chicago, Illinois, United States, 60637

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02241

Children's Minnesota

Recruiting

Saint Paul, Minnesota, United States, 55102

Children's Mercy

Recruiting

Kansas City, Missouri, United States, 64108

The Washington University

Recruiting

Saint Louis, Missouri, United States, 63110

Children's Omaha

Recruiting

Omaha, Nebraska, United States, 68114

Weil Cornell Medical College

Recruiting

New York, New York, United States, 10021

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205-2664

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

The Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19146

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Monroe Carell Jr. Children's Hospital at Vanderbilt

Recruiting

Nashville, Tennessee, United States, 37232

Ascension Seton Medical Center

Recruiting

Austin, Texas, United States, 78705

University of Texas Southwest Medical Center (UTSW)

Recruiting

Dallas, Texas, United States, 75390

MD Anderson

Recruiting

Houston, Texas, United States, 77030

Seattle Children's Research Institute

Recruiting

Seattle, Washington, United States, 98105

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1E8

More Information

Sponsor

Arkansas Children's Hospital Research Institute

Last update posted

Sep 25, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute on 2024-09-25.