Evaluation of NGS for Detection and Follow-up of Fungal Pathogens in Immunocompromised Pediatric Patients

Karius, Inc.40 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Invasive Fungal Disease Fever and Neutropenia Invasive Fungal Infections Immunocompromised

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Prolonged FN (≥96 hours) despite broad-spectrum antibiotic therapy with anticipated delayed neutrophil recovery * Any findings that trigger the primary team to consider new fungal infection in a given inpatient, such as abnormal imaging results, recrudescent fevers in the setting of neutropenia or characteristic skin rashes Exclusion Criteria: -Those without concern for fungal infection or those currently being treated for a presumed or documented fungal infection will not be recruited for this study

Locations (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Incidence of positivity for fungal specific pathogens on NGS analysis

We aim to describe the incidence of positivity for fungal specific pathogens on NGS analysis in a high-risk immunocompromised pediatric population.

Time frame: 7 months

Data from ClinicalTrials.gov

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