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



Status:Recruiting
Healthy:No
Age Range:Any - 18
Updated:6/8/2018
Start Date:January 2015
End Date:May 2019
Contact:William J Steinbach, MD
Email:bill.steinbach@duke.edu

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Fungal Biomarkers for Diagnosis and Response to Therapy for Pediatric

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.

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.

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
We found this trial at
20
sites
1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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Memphis, TN
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Orange, CA
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Austin, Texas 78723
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Cincinnati, Ohio 45267
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Cleveland, Ohio
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Kansas City, Missouri 64108
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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New Hyde Park, New York 11040
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
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Saint Petersburg, Florida 33701
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San Diego, California 92123
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San Francisco, California 94143
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