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

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ClinicalTrials.gov Identifier: NCT03262584
Recruitment Status : Completed
First Posted : August 25, 2017
Last Update Posted : October 29, 2018
Sponsor:
Collaborator:
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Karius, Inc.

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
Invasive Fungal Disease Fever and Neutropenia Invasive Fungal Infections Immunocompromised

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 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 : July 31, 2018
Actual Study Completion Date : September 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Molds




Primary Outcome Measures :
  1. Incidence of positivity for fungal specific pathogens on NGS analysis [ Time Frame: 7 months ]
    We aim to describe the incidence of positivity for fungal specific pathogens on NGS analysis in a high-risk immunocompromised pediatric population.


Biospecimen Retention:   Samples Without DNA
Plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients treated at Ann & Robert H. Lurie Children's Hospital of Chicago on the hematology, oncology, neuro-oncology and stem cell transplant unit
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262584


Locations
United States, Illinois
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

Responsible Party: Karius, Inc.
ClinicalTrials.gov Identifier: NCT03262584     History of Changes
Other Study ID Numbers: KDP-001
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neutropenia
Mycoses
Invasive Fungal Infections
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases