Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections
- Conditions
- Pulmonary Invasive Fungal InfectionsPulmonary Invasive Aspergillosis
- Interventions
- Diagnostic Test: Non-Invasive Testing for PIFI
- Registration Number
- NCT03827694
- Lead Sponsor
- Arkansas Children's Hospital Research Institute
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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
- Weight <3 kg, so as to not exceed 3 ml/kg in a single blood draw
- Previous inclusion in this study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with possible PIFI Non-Invasive Testing for PIFI -
- Primary Outcome Measures
Name Time Method Likelihood ratio of the galactomannan assay to return a positive result among subjects determined to have PIFI Baseline Likelihood ratio of galactomannan assay to return a negative result among subjects determined not to have PIFI Baseline Likelihood ratio of cell-free next generation DNA/RNA sequencing identifying a fungal pathogen to return a positive result among subjects determined to have PIFI Baseline Likelihood ratio of cell-free next generation DNA/RNA sequencing identifying a fungal pathogen to return a negative result among subjects determined not to have PIFI Baseline Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a positive result among subjects determined to have PIFI Baseline Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a negative result among subjects determined not to have PIFI Baseline Likelihood ratio of molecular RNAseq platform assessing host immune response to return a positive result among subjects determined to have PIFI Baseline Likelihood ratio of molecular RNAseq platform assessing host immune response to return a negative result among subjects determined not to have PIFI Baseline
- Secondary Outcome Measures
Name Time Method Composite outcome score between patients with possible pulmonary invasive fungal infection managed with empirical antifungal therapy versus an invasive diagnostic procedure 49 days Outcome score inclusive of outcomes and adverse events. Comprehensive clinical outcome score from most to least desirable are score of 1 (survival, improvement in pulmonary nodules, no adverse events related to anti-fungal therapy or invasive diagnostic intervention) to score of 7 (death)
Trial Locations
- Locations (33)
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Arkansas Children's Research Institute
🇺🇸Little Rock, Arkansas, United States
Rady Children's Hospital, UCSD
🇺🇸La Jolla, 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, District of Columbia, United States
All Children's Research Institute
🇺🇸Saint 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
🇺🇸Saint 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
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, 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