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Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

RecruitingObservational study

Who can join

120 Days – 21 Years · All sexes

Full eligibility criteria
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

About the study

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

What is being tested

Sponsor: Arkansas Children's Hospital Research Institute · Participants: 400 · Started: Oct 30, 2018

Contact the study team

Official record on ClinicalTrials.gov — NCT03827694

Locations in the U.S.

ArkansasArkansas Children's Research Institute, Little Rock
CaliforniaRady Children's Hospital, UCSD, La Jolla
Children's Hospital of Orange County, Orange
Lucile Packard Children's Hospital, Stanford University, Palo Alto
ConnecticutYale University, New Haven
District of ColumbiaChildren's National Hospital, Washington D.C.
GeorgiaEmory University-Children's Healthcare of Atlanta (CHOA), Atlanta
IllinoisAnn & Robert H. Lurie Children's Hospital of Chicago, Chicago
University of Chicago Medicine, Comer Children's, Chicago
IndianaIndiana University School of Medicine, Indianapolis
MassachusettsBoston Children's Hospital, Boston
MinnesotaChildren's Minnesota, Saint Paul
MissouriChildren's Mercy, Kansas City
The Washington University, St Louis
NebraskaChildren's Omaha, Omaha
New YorkWeil Cornell Medical College, New York
OhioCincinnati Children's Hospital Medical Center, Cincinnati
Nationwide Children's Hospital, Columbus
OregonOregon Health and Science University, Portland
PennsylvaniaThe Children's Hospital of Philadelphia, Philadelphia
TennesseeSt. Jude Children's Research Hospital, Memphis
Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville
TexasAscension Seton Medical Center, Austin
University of Texas Southwest Medical Center (UTSW), Dallas
MD Anderson, Houston
WashingtonSeattle Children's Research Institute, Seattle
WisconsinMedical College of Wisconsin, Milwaukee

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.