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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Fungal Biomarkers for Diagnosis and Response to Therapy for Pediatric

Brief 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.

Detailed Summary:

This study will create an international multi-center cohort of children with new clinical concern for infection while in the ICU. The study will be collected at 23 US sites and 18 International sites; other sites may be added in the future. Sites used are part of the International Pediatric Fungal Network (PFN; www.ipfn.org). We plan to enroll a total of 500 high-risk inpatients over the course of four years. The study plans to prospectively enroll pediatric ICU patients at high-risk of developing invasive candidiasis over a four year period. The study duration per subject will be up to 14 days for blood collection and 30 days for data collection from the medical record. Additionally, inpatient clinical data up to 14 days prior to the first blood draw will be collected. The subject will be participating in the study up to 30 days from the day the first blood draw is collected.

For the first aim, this 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. To accomplish the second aim, additional blood sampling will be performed in the sub-set of patients that are found to have invasive candidiasis. For the third aim, leftover blood samples following biomarker testing from all consenting participants will be stored in a biobank. This biobank will be used to examine future, currently undeveloped, biomarker assays in an effort to further reduce the time to diagnosis of invasive candidiasis.


Sponsor: Duke University

Current Primary Outcome: NPV, PPV, sensitivity, specificity, and threshold for positive result of fungal biomarker assays [ Time Frame: 1 day ]

Operating characteristics of fungal biomarker assays in pediatric patients at high-risk for developing invasive candidiasis


Original Primary Outcome: Same as current

Current Secondary Outcome: change in fungal biomarker assay results [ Time Frame: 14 days ]

Measure the change in fungal biomarker assay results in those children who developed invasive candidiasis in order to monitor their response to therapy


Original Secondary Outcome: Same as current

Information By: Duke University

Dates:
Date Received: August 15, 2014
Date Started: January 2015
Date Completion: April 2018
Last Updated: July 20, 2016
Last Verified: July 2016