Status:
RECRUITING
Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections
Lead Sponsor:
Arkansas Children's Hospital Research Institute
Collaborating Sponsors:
Children's Hospital of Philadelphia
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Pulmonary Invasive Fungal Infections
Pulmonary Invasive Aspergillosis
Eligibility:
All Genders
120-21 years
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).
Eligibility Criteria
Inclusion
- 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
- Weight \<3 kg, so as to not exceed 3 ml/kg in a single blood draw
- Previous inclusion in this study
Key Trial Info
Start Date :
October 30 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03827694
Start Date
October 30 2018
End Date
December 31 2026
Last Update
September 25 2024
Active Locations (33)
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1
Arkansas Children's Research Institute
Little Rock, Arkansas, United States, 72202
2
Rady Children's Hospital, UCSD
La Jolla, California, United States, 92093
3
Children's Hospital of Orange County
Orange, California, United States, 92868
4
Lucile Packard Children's Hospital, Stanford University
Palo Alto, California, United States, 94305