Evaluation of NGS for Detection and Follow-up of Fungal Pathogens in Immunocompromised Pediatric Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03262584|
Recruitment Status : Completed
First Posted : August 25, 2017
Last Update Posted : October 29, 2018
|Condition or disease|
|Invasive Fungal Disease Fever and Neutropenia Invasive Fungal Infections Immunocompromised|
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|
|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|
- 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
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
|United States, Illinois|
|Ann & Robert H. Lurie Children's Hospital of Chicago|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Amy Armstrong, MD||Ann & Robert H Lurie Children's Hospital of Chicago|