Invasive Fungal Infections Clinical Trial
Official title:
Evaluation of NGS for Detection and Follow-up of Fungal Pathogens in Immunocompromised Pediatric Patients
The Sponsor hypothesize that Next-generation Sequencing (NGS) can identify fungal pathogens, is more accurate than other noninvasive options and can report fungal genomic load.
The Sponsor aims to describe the incidence of positivity for fungal specific pathogens on NGS
analysis in a high-risk immunocompromised pediatric population.
Secondarily, the Sponsor will correlate results of the NGS analysis to other approved fungal
tests if performed at the discretion of the treating provider (e.g. blood culture results,
radiographic findings, biopsy results, bronchoalveolar lavage findings, galactomannan results
or b-D-glucan (BG) results as evaluated via FDA-approved "Fungitell" assay). The Sponsor will
use these other fungal tests, in addition to clinical criterion, to classify subjects as
having possible, probable and proven IFD according to established criteria, and compare these
categories against results from NGS analysis.
Lastly, to quantitatively evaluate follow-up test results to determine fungal DNA genomic
load in subjects with positive results.
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