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Comparison of Uncomplicated Candidemia Therapy Duration in Children
Sponsor: Arkansas Children's Hospital Research Institute
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.
Official title: Short Course Versus Standard Course Antifungal Therapy for Uncomplicated Candidemia in Children and Adolescents: A Multi-Center Randomized Controlled Trial
Key Details
Gender
All
Age Range
120 Days - 18 Years
Study Type
INTERVENTIONAL
Enrollment
420
Start Date
2023-09-08
Completion Date
2032-06-30
Last Updated
2025-05-11
Healthy Volunteers
No
Conditions
Interventions
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
Locations (17)
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