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Completed No phase listed Observational

BIOPIC: Fungal Biomarkers for Diagnosis and Response to Therapy for Pediatric Candidemia

ClinicalTrials.gov ID: NCT02220790

Public ClinicalTrials.gov record NCT02220790. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 8:41 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Fungal Biomarkers for Diagnosis and Response to Therapy for Pediatric

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of the study is to 1) define the operating characteristics of fungal biomarker assays in pediatric patients at high-risk for developing invasive candidiasis, 2) determine the change in fungal biomarker assay results in children who develop invasive candidiasis, and 3) create a biobank of blood samples from pediatric patients at high-risk for invasive candidiasis and those with invasive candidiasis for future testing of fungal biomarker assays and development of new fungal biomarker assays. The study will assemble a prospective cohort of pediatric patients at high-risk for developing invasive candidiasis. Blood samples for biomarker testing will be obtained at the time a patient has a clinical indication for blood culture attainment. Additional blood sampling will be performed on the sub-set of patients that are found to have invasive candidiasis. The sensitivity, specificity, PPV, and NPV of biomarker assays will be determined for each biomarker assay. No PHI will be stored in the database and limits on blood draws (3 ml/kg in an 8 week period) will be adhered to.

Study identification

NCT ID
NCT02220790
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Duke University
Other
Enrollment
515 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
120 Days to 18 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 2015 (Type not available)
Primary completion
Oct 8, 2020 (Actual)
Completion
Oct 8, 2020 (Actual)
Last update posted
Feb 28, 2022

2015 – 2020

United States locations

U.S. sites
19
U.S. states
13
U.S. cities
19
Facility City State ZIP Site status
Arkansas Children's Hospital Little Rock Arkansas — —
Children's Hospital of Orange County Orange California — —
Rady Children's Hospital San Diego California — —
UCSF Benioff Children's Hospital San Francisco California — —
All Children's Hospital St. Petersburg Florida — —
Ann and Robert Lurie Children's Hospital of Chicago Chicago Illinois — —
Boston Children's Hospital Boston Massachusetts — —
Children's Mercy Kansas City Missouri — —
Cohen Children's Medical Center of New York New Hyde Park New York — —
New York-Presbyterian Phyllis and David Komansky Center for Children's Health New York New York — —
Duke University Durham North Carolina 27710 —
Cincinnati Children's Medical Center Cincinnati Ohio — —
Cleveland Clinic Children's Cleveland Ohio — —
Children's Hospital of Philadelphia Philadelphia Pennsylvania — —
Children's Hospital of Pittsburgh Pittsburgh Pennsylvania — —
St Jude Children's Research Hospital Memphis Tennessee — —
Dell Children's Medical Center Austin Texas — —
Texas Children's Hospital Houston Texas — —
Medical College of Wisconsin Milwaukee Wisconsin — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02220790, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 28, 2022 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02220790 live on ClinicalTrials.gov.

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