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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-17

Study Completion Date

2018-09-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Studies of Disorders With Increased Susceptibility to Fungal Infections

NCT01222741

Fungal Infections Primary Immune Deficiencies

RECRUITING

Characterizing Diversity and Antifungal Resistance in Immunocompromised ICU Patients With Respiratory Tract Infections

NCT06387667

Immunocompromised ICU Patients With Respiratory Tract Infections

NOT_YET_RECRUITING NA

Optimized Diagnostics for Improved Therapy Stratification in Invasive Fungal Infections

NCT02492594

Systemic Mycosis

COMPLETED

Funguria in Hospitalized Patients

NCT00138502

Candidiasis

COMPLETED

Interest of Real-time Polymerase Chain Reaction (PCR) in the Diagnosis of Fungal Infections

NCT00876096

Healthy Fungal Infections

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Invasive Fungal Disease Fever and Neutropenia Invasive Fungal Infections Immunocompromised

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No