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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 : July 13, 2017
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Duke University

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.

Condition or disease
Invasive Candidiasis

Detailed Description:

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 : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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 : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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
Blood samples


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Ages Eligible for Study:   120 Days to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will create an international multi-center cohort of children with new clinical concern for infection while in the hospital.
Criteria

Inclusion Criteria:

  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 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
  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 or sterile site culture for Candida spp. that turns positive between day 0 and day +14.

Exclusion Criteria:

  1. Diagnosis of an invasive fungal disease within the 30 days prior to the blood culture drawn of clinical concern of infection.
  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 anti-fungal 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

Information from the National Library of Medicine

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


Contacts
Contact: William J Steinbach, MD bill.steinbach@duke.edu

  Show 22 Study Locations
Sponsors and Collaborators
Duke University
Children's Hospital of Philadelphia
Investigators
Principal Investigator: William J Steinbach, MD Duke University
Principal Investigator: Brian T Fisher, DO, MPH, MSCE Children's Hospital of Philadelphia

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02220790     History of Changes
Other Study ID Numbers: Pro00056090
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017

Keywords provided by Duke University:
IPFN
Pediatric
Fungal
Biomarker Assays
Candida
Pediatric ICU patient

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Invasive
Mycoses
Invasive Fungal Infections