Status:

COMPLETED

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

Lead Sponsor:

Karius, Inc.

Collaborating Sponsors:

Ann & Robert H Lurie Children's Hospital of Chicago

Conditions:

Invasive Fungal Disease

Fever and Neutropenia

Eligibility:

All Genders

Brief 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 r...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 17 2017

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 28 2018

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT03262584

Start Date

May 17 2017

End Date

September 28 2018

Last Update

June 17 2019

Active Locations (1)

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1

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

Chicago, Illinois, United States, 60611