BIOPIC: Fungal Biomarkers for Diagnosis and Response to Therapy for Pediatric Candidemia (BIOPIC)
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|ClinicalTrials.gov Identifier: NCT02220790|
Recruitment Status : Recruiting
First Posted : August 20, 2014
Last Update Posted : August 11, 2020
|Condition or disease|
This study will create an international multi-center cohort of children with new clinical concern for infection while in the hospital. Sites used are part of the International Pediatric Fungal Network (ipfn.org). The study plans to prospectively enroll pediatric 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.
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 within 24-hours of a patient having 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, remnant 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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||515 participants|
|Target Follow-Up Duration:||30 Days|
|Official Title:||Fungal Biomarkers for Diagnosis and Response to Therapy for Pediatric|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||September 15, 2020|
|Estimated Study Completion Date :||September 30, 2020|
- 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
- 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
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220790
|Contact: William J Steinbach, MDemail@example.com|
|Principal Investigator:||William J Steinbach, MD||Duke University|
|Principal Investigator:||Brian T Fisher, DO, MPH, MSCE||Children's Hospital of Philadelphia|