NCT03262584

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Karius, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Invasive Fungal Disease
• Fever and Neutropenia
• Invasive Fungal Infections
• Immunocompromised

Timeline

• Start date: 2017-05-17
• Primary completion: 2018-07-31
• Completion: 2018-09-28
• First posted: 2017-08-25
• Last updated: 2019-06-17

Locations

1 site across 1 country: United States