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

Invasive Fungal Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03262584
• Other study ID #: KDP-001
• Status: Completed
• Start date: May 17, 2017
• Est. completion date: September 28, 2018

Study information

• Verified date: June 2019
• Source: Karius, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 28, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Karius, Inc.	Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 months