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NCT02220790 · ClinicalTrials.gov registry record
BIOPIC: Fungal Biomarkers for Diagnosis and Response to Therapy for Pediatric Candidemia
A clinical trial, sponsored by Duke University.
- Completed
- Registry status
- 515
- Enrollment target
NCT02220790: Completed study, sponsored by Duke University.
NCT02220790 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 515 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02220790 has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 515 participants
- Enrollment target
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.
Primary Outcome
Operating characteristics of fungal biomarker assays in pediatric patients at high-risk for developing invasive candidiasis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 515 participants |
| Start Date | 2015-01 |
| Est. Completion | 2020-10-08 |
What the finished NCT02220790 record still lists
NCT02220790 is an observational study that tracks outcomes without assigning an intervention. The registered 515 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02220790 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02220790 about?
NCT02220790 is a clinical study titled "BIOPIC: Fungal Biomarkers for Diagnosis and Response to Therapy for Pediatric Candidemia". 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...
What is the current status of trial NCT02220790?
This trial is currently completed. The enrollment target is 515 participants. The study started on 2015-01. Estimated completion is 2020-10-08.
Who is sponsoring clinical trial NCT02220790?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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