Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections
NCT ID: NCT03827694
Last Updated: 2024-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2018-10-30
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with possible PIFI
Non-Invasive Testing for PIFI
galactomannan assay, fungal PCRs, cell-free next-generation DNA/RNA sequencing, RNAseq
Interventions
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Non-Invasive Testing for PIFI
galactomannan assay, fungal PCRs, cell-free next-generation DNA/RNA sequencing, RNAseq
Eligibility Criteria
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Inclusion Criteria
* 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
* Previous inclusion in this study
120 Days
21 Years
ALL
No
Sponsors
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Children's Hospital of Philadelphia
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Arkansas Children's Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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William Steinbach
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Brian Fisher
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Arkansas Children's Research Institute
Little Rock, Arkansas, United States
Rady Children's Hospital, UCSD
La Jolla, California, United States
Children's Hospital of Orange County
Orange, California, United States
Lucile Packard Children's Hospital, Stanford University
Palo Alto, California, United States
University of California San Francisco, Benioff Children's Hospital
San Francisco, California, United States
Yale University
New Haven, Connecticut, United States
Children's National Hospital
Washington D.C., District of Columbia, United States
All Children's Research Institute
St. Petersburg, Florida, United States
Emory University-Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Chicago Medicine, Comer Children's
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Minnesota Medical School
Minneapolis, Minnesota, United States
Children's Minnesota
Saint Paul, Minnesota, United States
Children's Mercy
Kansas City, Missouri, United States
The Washington University
St Louis, Missouri, United States
Children's Omaha
Omaha, Nebraska, United States
Weil Cornell Medical College
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Ascension Seton Medical Center
Austin, Texas, United States
University of Texas Southwest Medical Center (UTSW)
Dallas, Texas, United States
MD Anderson
Houston, Texas, United States
Seattle Children's Research Institute
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Central Contacts
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Other Identifiers
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Pro00094558
Identifier Type: -
Identifier Source: org_study_id
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