Status:
COMPLETED
BIOPIC: Fungal Biomarkers for Diagnosis and Response to Therapy for Pediatric Candidemia
Lead Sponsor:
Duke University
Collaborating Sponsors:
Children's Hospital of Philadelphia
Conditions:
Invasive Candidiasis
Eligibility:
All Genders
120-18 years
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 fun...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Diagnosis of an invasive fungal disease within the 30 days prior to the blood culture drawn of clinical concern of infection.
- Previous inclusion in this study
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 8 2020
Estimated Enrollment :
515 Patients enrolled
Trial Details
Trial ID
NCT02220790
Start Date
January 1 2015
End Date
October 8 2020
Last Update
February 28 2022
Active Locations (22)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States
2
Children's Hospital of Orange County
Orange, California, United States
3
Rady Children's Hospital
San Diego, California, United States
4
UCSF Benioff Children's Hospital
San Francisco, California, United States