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

NCT02220790 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 515

Last updated 2022-02-28

No results posted yet for this study

Summary

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.

Conditions

  • Invasive Candidiasis

Sponsors & Collaborators

Principal Investigators

  • William J Steinbach, MD · Duke University

  • Brian T Fisher, DO, MPH, MSCE · Children's Hospital of Philadelphia

Eligibility

Min Age
120 Days
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2020-10-08
Completion
2020-10-08

Countries

  • United States
  • Greece
  • Saudi Arabia
  • Spain

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02220790 on ClinicalTrials.gov