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

Invasive Candidiasis Clinical Trial

— BIOPIC  

Official title:

Fungal Biomarkers for Diagnosis and Response to Therapy for Pediatric

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02220790
• Other study ID #: Pro00056090
• Status: Completed
• Start date: January 2015
• Est. completion date: October 8, 2020

Study information

• Verified date: August 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 515
• Est. completion date: October 8, 2020
• Est. primary completion date: October 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 120 Days to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Invasive
• Invasive Candidiasis

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Children's Hospital of Philadelphia

Countries where clinical trial is conducted

United States,  Greece,  Saudi Arabia,  Spain, 

References & 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-Pala — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	change in fungal biomarker assay results	Measure the change in fungal biomarker assay results in those children who developed invasive candidiasis in order to monitor their response to therapy	14 days