Clinical Trial

Comparison of Uncomplicated Candidemia Therapy Duration in Children

Study acronym: COUNT
Recruiting
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-03-08; most recent amendment 2026-04-15.
Status change: Not Yet Recruiting → Recruiting 2023-07-12
Trial Details
NCT Number NCT05763251
Lead Sponsor Arkansas Children's Hospital Research Institute
Collaborators: Westat, St. Jude Children's Research Hospital, George Washington University, Children's Hospital of Philadelphia, National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Invasive Candidiasis
Enrollment 420 participants
Start Date 2023-09-08
Primary Completion 2030-06-30 (estimated)
Study Completion 2032-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-17