Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

Status: Recruiting
Location: See all (33) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 4 months
Maximum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
United States
Arkansas
Arkansas Children's Research Institute
RECRUITING
Little Rock
California
Rady Children's Hospital, UCSD
RECRUITING
La Jolla
Children's Hospital of Orange County
RECRUITING
Orange
Lucile Packard Children's Hospital, Stanford University
RECRUITING
Palo Alto
University of California San Francisco, Benioff Children's Hospital
WITHDRAWN
San Francisco
Connecticut
Yale University
RECRUITING
New Haven
Washington, D.c.
Children's National Hospital
RECRUITING
Washington D.c.
Florida
All Children's Research Institute
ACTIVE_NOT_RECRUITING
St. Petersburg
Georgia
Emory University-Children's Healthcare of Atlanta (CHOA)
RECRUITING
Atlanta
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
University of Chicago Medicine, Comer Children's
RECRUITING
Chicago
Indiana
Indiana University School of Medicine
RECRUITING
Indianapolis
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Minnesota
University of Minnesota Medical School
ACTIVE_NOT_RECRUITING
Minneapolis
Children's Minnesota
RECRUITING
Saint Paul
Missouri
Children's Mercy
RECRUITING
Kansas City
The Washington University
RECRUITING
St Louis
North Carolina
Duke University Medical Center
ACTIVE_NOT_RECRUITING
Durham
Nebraska
Children's Omaha
RECRUITING
Omaha
New York
Weil Cornell Medical College
RECRUITING
New York
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Cleveland Clinic
WITHDRAWN
Cleveland
Nationwide Children's Hospital
RECRUITING
Columbus
Oregon
Oregon Health and Science University
RECRUITING
Portland
Pennsylvania
The Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Tennessee
St. Jude Children's Research Hospital
RECRUITING
Memphis
Monroe Carell Jr. Children's Hospital at Vanderbilt
RECRUITING
Nashville
Texas
Ascension Seton Medical Center
RECRUITING
Austin
University of Texas Southwest Medical Center (UTSW)
RECRUITING
Dallas
MD Anderson
RECRUITING
Houston
Washington
Seattle Children's Research Institute
RECRUITING
Seattle
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Canada
The Hospital for Sick Children
RECRUITING
Toronto
Contact Information
Primary
PFN Central Coordinator
PFNClinical@uams.edu
501-364-3057
Time Frame
Start Date: 2018-10-30
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 400
Treatments
Patients with possible PIFI
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Children's Hospital of Philadelphia
Leads: Arkansas Children's Hospital Research Institute

This content was sourced from clinicaltrials.gov