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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03262584

Enrollment

Registered

2017-08-25

Start date

2017-05-17

Completion date

2018-09-28

Last updated

2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results