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

Completed

Conditions studied: Invasive Candidiasis

In brief

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.

Key facts

Study ID

NCT02220790

Run by

Duke University

People needed

515

Starts

2015-01-01

Expected to finish

2020-10-08

Last updated by the study team

2022-02-28

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females age > 120 days and <18 years
• Have at least one of the following conditions:
• admitted to a non-neonatal ICU with any underlying disease
• being transferred imminently to a non-neonatal ICU with any underlying disease
• have gastro-intestinal insufficiency (eg. chronic short-gut syndrome) and admitted to anywhere in the hospital
• have a hematological malignancy (limited to AML, ALL, non-Hodgkin's lymphoma and myelodysplastic syndrome) and admitted to anywhere to the hospital
• have a solid tumor malignancy and admitted to anywhere in the hospital
• have a solid organ transplant and be admitted to anywhere in the hospital
• have a hemopoietic stem cell or bone marrow transplant and be admitted to anywhere in the hospital
• have aplastic anemia and be admitted to anywhere in the hospital
• Have ≥ 1 central catheter (arterial or venous)
• Have ≥ 1 blood culture drawn for clinical concern of infection at time of enrollment
• Clinician initiates and/or changes any systemic antimicrobial therapy at time of enrollment
• Parental/guardian permission (informed consent) and, if appropriate, child assent.
• For Aim 2: Each of the above AND a positive blood culture or sterile site culture for Candida spp. that turns positive between day 0 and day +14.

You may not qualify if…

• Diagnosis of an invasive fungal disease within the 30 days prior to the blood culture drawn of clinical concern of infection.
• Previous inclusion in this study
• Weight < 4 kg (Due to constraints of no more than 3 ml/kg of blood to be drawn over an 8 week period). Subjects that fall below 4 kg during the study period that blood draws are occurring will not have more than 0.75 ml/kg of blood drawn each time.
• Patient receiving empiric anti-fungal therapy for prolonged neutropenia or fever that was started prior to the time of blood culture
• If blood cultures obtained and anti-infectives are added/changed only as part of a local protocol and not dictated by clinical concern of infection

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Children's Hospital of Orange County — Orange, California, United States
• Rady Children's Hospital — San Diego, California, United States
• UCSF Benioff Children's Hospital — San Francisco, California, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• Ann and Robert Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Children's Mercy — Kansas City, Missouri, United States
• Cohen Children's Medical Center of New York — New Hyde Park, New York, United States
• New York-Presbyterian Phyllis and David Komansky Center for Children's Health — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• Cincinnati Children's Medical Center — Cincinnati, Ohio, United States
• Cleveland Clinic Children's — Cleveland, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• St Jude Children's Research Hospital — Memphis, Tennessee, United States
• Dell Children's Medical Center — Austin, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• 3rd Department Pediatrics Aristole University School of Medicine, Hippokration Hospital — Thessaloniki, Greece
• King Faisal Specialist Hospital and Research Center — Riyadh, Saudi Arabia
• Hospital d'Unverisitari Vall d'Hebron — Barcelona, Spain

Full record on ClinicalTrials.gov

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