Comparison of Uncomplicated Candidemia Therapy Duration in Children
NCT ID: NCT05763251
Last Updated: 2025-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
420 participants
INTERVENTIONAL
2023-09-08
2032-06-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Short-course therapy
pediatric patients with uncomplicated candidemia who have already received 7 days of primary systemic antifungal therapy will receive no additional antifungal therapy
therapy duration
the standard-course arm will receive 14 days total of antifungal therapy and the short-course arm will only receive 7 days of therapy
Standard-course therapy
pediatric patients with uncomplicated candidemia who have already received 7 days of primary systemic antifungal therapy will receive 7 additional days of systemic antifungal therapy
No interventions assigned to this group
Interventions
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therapy duration
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
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Inclusion Criteria
2. Candidemia with at least one positive blood culture for any Candida spp;
3. Receiving/received an echinocandin (caspofungin, micafungin or anidulafungin) 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);
4. Sustained clearance of Candida spp. from repeat blood culture(s) obtained on or before day of randomization;
5. Partial or complete clinical response, as defined by published guidelines, on or before day of randomization;
6. No evidence of metastatic foci of infection at the time of randomization, as documented by a negative abdominal ultrasound or abdominal CT scan of the liver, spleen, and kidneys and negative ophthalmologic examination.
Exclusion Criteria
2. Neutropenic (absolute neutrophil count \< 500 cells/μl) at the time of enrollment or anticipated to be neutropenic in the week following randomization;
3. Have an underlying condition that requires them to be on antifungal prophylaxis when not receiving directed therapy for an invasive fungal disease;
4. Previous enrollment in this trial.
5. Females of childbearing age with a current pregnancy diagnosis or without a negative pregnancy test for their current admission
6. A documented DNR order
7. Have an implantable cardiac device (e.g., ventricular assist device, pacemaker)
120 Days
18 Years
ALL
No
Sponsors
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Westat
OTHER
St. Jude Children's Research Hospital
OTHER
George Washington University
OTHER
Children's Hospital of Philadelphia
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Arkansas Children's Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Brian Fisher, DO
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
William J Steinbach, MD
Role: PRINCIPAL_INVESTIGATOR
Arkansas Children's Hospital Research Institute
Locations
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Children's Hospital of Alabama
Birmingham, Alabama, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital of Orange County
Orange, California, United States
Yale New Haven Children's Hospital
New Haven, Connecticut, United States
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Comer Children's Hospital
Chicago, Illinois, United States
Riley Children's Hospital
Indianapolis, Indiana, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Washington University St. Louis
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Weill Cornell Medical College
New York, New York, United States
Duke Children's Hospital
Durham, North Carolina, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Dell Children's Medical Center
Austin, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-020057
Identifier Type: -
Identifier Source: org_study_id
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