Comparison of Uncomplicated Candidemia Therapy Duration in Children
COUNT
Short Course Versus Standard Course Antifungal Therapy for Uncomplicated Candidemia in Children and Adolescents: A Multi-Center Randomized Controlled Trial
2 other identifiers
interventional
420
2 countries
22
Brief Summary
The goal of this clinical trial is to compare antifungal therapy duration in pediatric uncomplicated candidemia. The specific aims are:
- Compare the desirability of outcome ranking in children with uncomplicated candidemia randomized to 7 additional days of antifungal therapy (standard-course) versus no additional antifungal therapy (short-course) after already receiving 7 days of echinocandin therapy.
- Compare the 14-day desirability of outcome measure for subjects with a negative and those with a positive T2Candida® biomarker at day 7 of therapy within randomized groups. Participants meeting eligibility criteria will be approached and consented between day 5 and 7 of primary systemic antifungal therapy. On day 7 of primary systemic antifungal therapy, inclusion and exclusion criteria will again be reviewed for consented patients and those still eligible will be randomized 1:1 to the two study arms. Researchers will compare no additional antifungal therapy (short-course) versus 7 additional days of systemic antifungal therapy (standard-course) in pediatric patients with uncomplicated candidemia who have already received 7 days of primary systemic antifungal therapy to see if shorter durations are as effective as longer durations in treating uncomplicated candidemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2023
CompletedFirst Posted
Study publicly available on registry
March 10, 2023
CompletedStudy Start
First participant enrolled
September 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2032
April 17, 2026
April 1, 2026
6.8 years
February 23, 2023
April 15, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Compare the desirability of outcome ranking (DOOR) in short-course vs standard-course arm
The primary analysis for the primary objective will compare the DOOR distributions at 7 days from randomization (i.e., outcome assessment on Day 14 from first negative blood culture) between subjects from the two study groups, based on randomized treatment assignments, in accordance with the intention-to-treat principle. The primary analysis will use the DOORs assigned on this day to assess which therapy course is better, short-course or standard-course.
The measures assigned on Day 14 will inform the primary analysis for the primary objective
Secondary Outcomes (1)
Compare the DOOR for subjects with a negative vs positive T2 Candida® biomarker at day 7
The DOOR measure on Day 14 will be used for the primary analysis for the secondary objective.
Study Arms (2)
Short-course therapy
EXPERIMENTALpediatric patients with uncomplicated candidemia who have already received 7 days of primary systemic antifungal therapy will receive no additional antifungal therapy
Standard-course therapy
NO INTERVENTIONpediatric patients with uncomplicated candidemia who have already received 7 days of primary systemic antifungal therapy will receive 7 additional days of systemic antifungal therapy
Interventions
the standard-course arm will receive 14 days total of antifungal therapy and the short-course arm will only receive 7 days of therapy
Eligibility Criteria
You may qualify if:
- Age \> 120 days at the time of the first negative blood culture at any participating site;
- Candidemia with at least one positive blood culture for any Candida spp;
- Receiving/received an echinocandin (caspofungin, micafungin, anidulafungin, or rezafungin) as primary antifungal therapy for candidemia for at least 2 days from day of first negative culture with continuation of uninterrupted systemic antifungal therapy at the time of enrollment);
- Sustained clearance of Candida spp. defined as negative blood culture(s) obtained after onset of candidemia and before day of randomization;
- Partial or complete clinical response, as defined by published guidelines (Table 5), on or before day of randomization;
- Between the onset of qualifying candidemia and randomization, no suspicion of disseminated candidiasis by patient's clinical team or, if deemed clinically necessary, documented negative radiological imaging such as an abdominal ultrasound or abdominal CT scan.
You may not qualify if:
- Already receiving antifungal therapy for a previously diagnosed systemic invasive fungal disease;
- Neutropenic (absolute neutrophil count \< 500 cells/µl) at the time of enrollment or anticipated to be neutropenic in the week following randomization;
- Have an underlying condition that requires them to be on antifungal prophylaxis when not receiving directed therapy for an invasive fungal disease;
- Previous enrollment in this trial;
- Females of childbearing age with a current pregnancy diagnosis or without a negative pregnancy test for their current admission;
- A documented DNR order;
- Have an implantable cardiac device (e.g., ventricular assist device, pacemaker)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arkansas Children's Hospital Research Institutelead
- Westatcollaborator
- St. Jude Children's Research Hospitalcollaborator
- George Washington Universitycollaborator
- Children's Hospital of Philadelphiacollaborator
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
Study Sites (22)
Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Yale New Haven Children's Hospital
New Haven, Connecticut, 06510, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 31193, United States
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Comer Children's Hospital
Chicago, Illinois, 60637, United States
Riley Children's Hospital
Indianapolis, Indiana, 46202, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
CS Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Washington University St. Louis
St Louis, Missouri, 63130, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Duke Children's Hospital
Durham, North Carolina, 27705, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Dell Children's Medical Center
Austin, Texas, 78723, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Perth Children's Hospital
Perth, Western Australia, 6009, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Fisher, DO
Children's Hospital of Philadelphia
- PRINCIPAL INVESTIGATOR
William J Steinbach, MD
Arkansas Children's Hospital Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2023
First Posted
March 10, 2023
Study Start
September 8, 2023
Primary Completion (Estimated)
June 30, 2030
Study Completion (Estimated)
June 30, 2032
Last Updated
April 17, 2026
Record last verified: 2026-04