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

NCT02220790 | Completed DMC

• 1 other identifier: Pro00056090
• Study Type: observational
• Target: 515
• Locations: 4 countries
• Sites: 22

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.

Conditions

Invasive Candidiasis

Keywords

IPFN; Pediatric; Fungal; Biomarker Assays; Candida; Pediatric ICU patient

Outcome Measures

Primary Outcomes (1)

• NPV, PPV, sensitivity, specificity, and threshold for positive result of fungal biomarker assays

  Operating characteristics of fungal biomarker assays in pediatric patients at high-risk for developing invasive candidiasis

  1 day

Secondary Outcomes (1)

• change in fungal biomarker assay results

  14 days

Eligibility Criteria

• Age: 120 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

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.
• 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

Sponsors & Collaborators

• Duke University: lead
• Children's Hospital of Philadelphia: collaborator

Study Sites (22)

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Location

Children's Hospital of Orange County

Orange, California, United States

Location

Rady Children's Hospital

San Diego, California, United States

Location

UCSF Benioff Children's Hospital

San Francisco, California, United States

Location

All Children's Hospital

St. Petersburg, Florida, United States

Location

Ann and Robert Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Location

Boston Children's Hospital

Boston, Massachusetts, United States

Location

Children's Mercy

Kansas City, Missouri, United States

Location

Cohen Children's Medical Center of New York

New Hyde Park, New York, United States

Location

New York-Presbyterian Phyllis and David Komansky Center for Children's Health

New York, New York, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Medical Center

Cincinnati, Ohio, United States

Location

Cleveland Clinic Children's

Cleveland, Ohio, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Location

St Jude Children's Research Hospital

Memphis, Tennessee, United States

Location

Dell Children's Medical Center

Austin, Texas, United States

Location

Texas Children's Hospital

Houston, Texas, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Location

3rd Department Pediatrics Aristole University School of Medicine, Hippokration Hospital

Thessaloniki, Greece

Location

King Faisal Specialist Hospital and Research Center

Riyadh, Saudi Arabia

Location

Hospital d'Unverisitari Vall d'Hebron

Barcelona, Spain

Location

Related Publications (1)

• Fisher BT, Boge CLK, Xiao R, Shuster S, Chin-Quee D, Allen J, Shaheen S, Hayden R, Suganda S, Zaoutis TE, Chang YC, Yin DE, Huppler AR, Danziger-Isakov L, Muller WJ, Roilides E, Romero J, Sue PK, Berman D, Wattier RL, Halasa N, Pong A, Maron G, Soler-Palacin P, Hutto SC, Gonzalez BE, Salvatore CM, Rajan S, Green M, Doby Knackstedt E, Hauger SB, Steinbach WJ. Multicenter Prospective Study of Biomarkers for Diagnosis of Invasive Candidiasis in Children and Adolescents. Clin Infect Dis. 2022 Aug 25;75(2):248-259. doi: 10.1093/cid/ciab928.

  PMID: 35134165 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Candidiasis, Invasive; Torulopsis

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections

Study Officials

• William J Steinbach, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Brian T Fisher, DO, MPH, MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: August 20, 2014
• Study Start: January 1, 2015
• Primary Completion: October 8, 2020
• Study Completion: October 8, 2020
• Last Updated: February 28, 2022

Record last verified: 2020-08

Locations

GR (1); SA (1); US (19); ES (1)