This study will establish a non-invasive diagnostic approach and evaluate clinical outcomes for children at high-risk for pulmonary invasive fungal infection (PIFI).
Study Type
OBSERVATIONAL
Enrollment
400
galactomannan assay, fungal PCRs, cell-free next-generation DNA/RNA sequencing, RNAseq
Likelihood ratio of the galactomannan assay to return a positive result among subjects determined to have PIFI
Time frame: Baseline
Likelihood ratio of galactomannan assay to return a negative result among subjects determined not to have PIFI
Time frame: Baseline
Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a positive result among subjects determined to have PIFI
Time frame: Baseline
Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a negative result among subjects determined not to have PIFI
Time frame: 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
Time frame: 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
Time frame: Baseline
Likelihood ratio of molecular RNAseq platform assessing host immune response to return a positive result among subjects determined to have PIFI
Time frame: Baseline
Likelihood ratio of molecular RNAseq platform assessing host immune response to return a negative result among subjects determined not to have PIFI
Time frame: Baseline
Composite outcome score between patients with possible pulmonary invasive fungal infection managed with empirical antifungal therapy versus an invasive diagnostic procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Arkansas Children's Research Institute
Little Rock, Arkansas, United States
RECRUITINGRady Children's Hospital, UCSD
La Jolla, California, United States
RECRUITINGChildren's Hospital of Orange County
Orange, California, United States
RECRUITINGLucile Packard Children's Hospital, Stanford University
Palo Alto, California, United States
RECRUITINGUniversity of California San Francisco, Benioff Children's Hospital
San Francisco, California, United States
WITHDRAWNYale University
New Haven, Connecticut, United States
RECRUITINGChildren's National Hospital
Washington D.C., District of Columbia, United States
RECRUITINGAll Children's Research Institute
St. Petersburg, Florida, United States
ACTIVE_NOT_RECRUITINGEmory University-Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia, United States
RECRUITINGAnn & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
RECRUITING...and 23 more locations
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)
Time frame: 49 days