Actively Recruiting

Age: 120Days - 21Years
All Genders
NCT03827694

Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

Led by Arkansas Children's Hospital Research Institute · Updated on 2024-09-25

400

Participants Needed

33

Research Sites

426 weeks

Total Duration

On this page

Sponsors

A

Arkansas Children's Hospital Research Institute

Lead Sponsor

C

Children's Hospital of Philadelphia

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

Who Can Participate

Age: 120Days - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 33 locations

1

Arkansas Children's Research Institute

Little Rock, Arkansas, United States, 72202

Actively Recruiting

2

Rady Children's Hospital, UCSD

La Jolla, California, United States, 92093

Actively Recruiting

3

Children's Hospital of Orange County

Orange, California, United States, 92868

Actively Recruiting

4

Lucile Packard Children's Hospital, Stanford University

Palo Alto, California, United States, 94305

Actively Recruiting

5

University of California San Francisco, Benioff Children's Hospital

San Francisco, California, United States, 94143

Withdrawn

6

Yale University

New Haven, Connecticut, United States, 06520

Actively Recruiting

7

Children's National Hospital

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

Actively Recruiting

8

All Children's Research Institute

St. Petersburg, Florida, United States, 33701

Active, Not Recruiting

9

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

Atlanta, Georgia, United States, 30322

Actively Recruiting

10

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

Chicago, Illinois, United States, 60611

Actively Recruiting

11

University of Chicago Medicine, Comer Children's

Chicago, Illinois, United States, 60637

Actively Recruiting

12

Indiana University School of Medicine

Indianapolis, Indiana, United States, 46202

Actively Recruiting

13

Boston Children's Hospital

Boston, Massachusetts, United States, 02241

Actively Recruiting

14

University of Minnesota Medical School

Minneapolis, Minnesota, United States, 55455

Active, Not Recruiting

15

Children's Minnesota

Saint Paul, Minnesota, United States, 55102

Actively Recruiting

16

Children's Mercy

Kansas City, Missouri, United States, 64108

Actively Recruiting

17

The Washington University

St Louis, Missouri, United States, 63110

Actively Recruiting

18

Children's Omaha

Omaha, Nebraska, United States, 68114

Actively Recruiting

19

Weil Cornell Medical College

New York, New York, United States, 10021

Actively Recruiting

20

Duke University Medical Center

Durham, North Carolina, United States, 27710

Active, Not Recruiting

21

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

22

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Withdrawn

23

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205-2664

Actively Recruiting

24

Oregon Health and Science University

Portland, Oregon, United States, 97239

Actively Recruiting

25

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19146

Actively Recruiting

26

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Actively Recruiting

27

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States, 37232

Actively Recruiting

28

Ascension Seton Medical Center

Austin, Texas, United States, 78705

Actively Recruiting

29

University of Texas Southwest Medical Center (UTSW)

Dallas, Texas, United States, 75390

Actively Recruiting

30

MD Anderson

Houston, Texas, United States, 77030

Actively Recruiting

31

Seattle Children's Research Institute

Seattle, Washington, United States, 98105

Actively Recruiting

32

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

33

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G 1E8

Actively Recruiting

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Research Team

P

PFN Central Coordinator

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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