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

Sponsor
Karius, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03262584
Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago (Other)
40
Enrollment
1
Location
16.4
Actual Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of NGS for Detection and Follow-up of Fungal Pathogens in Immunocompromised Pediatric Patients
    Actual Study Start Date :
    May 17, 2017
    Actual Primary Completion Date :
    Jul 31, 2018
    Actual Study Completion Date :
    Sep 28, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of positivity for fungal specific pathogens on NGS analysis [7 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Karius, Inc.
    • Ann & Robert H Lurie Children's Hospital of Chicago

    Investigators

    • Principal Investigator: Amy Armstrong, MD, Ann & Robert H Lurie Children's Hospital of Chicago

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Karius, Inc.
    ClinicalTrials.gov Identifier:
    NCT03262584
    Other Study ID Numbers:
    • KDP-001
    First Posted:
    Aug 25, 2017
    Last Update Posted:
    Jun 17, 2019
    Last Verified:
    Jun 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Mycoses
    Invasive Fungal Infections
    Neutropenia

    Study Results

    No Results Posted as of Jun 17, 2019