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Eligibility
for people ages up to 18 years
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

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.

Official Title

Fungal Biomarkers for Diagnosis and Response to Therapy for Pediatric

Details

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.

Keywords

Invasive Candidiasis IPFN Pediatric Fungal Biomarker Assays Candida Pediatric ICU patient

Eligibility

You can join if…

Open to people ages up to 18 years

  1. Males or females age> 120 days and <18 years
  2. 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 myelodsyplastic 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 hemopoeitic 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
  3. Have ≥ 1 central catheter (arterial or venous)
  4. Have ≥ 1 blood culture drawn for clinical concern of infection at time of enrollment
  5. Clinician initiates and/or changes any systemic antimicrobial therapy at time of enrollment
  6. Parental/guardian permission (informed consent) and, if appropriate, child assent.
  7. For Aim 2: Each of the above AND a positive blood culture for Candida spp. that turns positive between day 0 and day +14.

You CAN'T join if...

  1. Diagnosis of an invasive fungal infection within the previous 30 days
  2. Previous inclusion in this study
  3. 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.
  4. Patient receiving empiric antifungal therapy for prolonged neutropenia or fever that was started prior to the time of blood culture
  5. 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

Locations

  • Children's Hospital of Orange County accepting new patients
    Orange, California, USA
  • Rady Children's Hospital accepting new patients
    San Diego, California, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Duke University
ID
NCT02220790
Study Type
Observational [Patient Registry]
Last Updated
July 2016
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