An observational study in Invasive Fungal Disease, Fever and Neutropenia and Invasive Fungal Infections, sponsored by Karius, Inc.. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2019-06-17.
Sponsored by Karius, Inc. · Observational
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.
136 studies on the registry are indexed under Invasive Fungal Infections; 33 are open to participants now.
This study's enrollment of 40 is below the median of 125 across 66 observational studies indexed under Invasive Fungal Infections.
Browse Invasive Fungal Infections studies →Karius, Inc. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
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Pediatric patients treated at Ann \& Robert H. Lurie Children's Hospital of Chicago on the hematology, oncology, neuro-oncology and stem cell transplant unit
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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
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
Ran from May 2017 to primary completion in Jul 2018, 14 months.
Of 30 observational studies under Invasive Fungal Infections, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 57. This study's 14 months is below that.
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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Karius, Inc.