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Invasive CandidiasisChildren's health

What this study is

The goal of this clinical trial is to compare antifungal therapy duration in uncomplicated candidemia. The specific aims are:

  • Compare the desirability of outcome ranking in patients 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.

What's being tested

  • therapy duration

    Intervention · OTHER

    the standard-course arm will receive 14 days total of antifungal therapy and the short-course arm will only receive 7 days of therapy

Study details

Official title
Short Course Versus Standard Course Antifungal Therapy for Uncomplicated Candidemia in Children and Adolescents: A Multi-Center Randomized Controlled Trial
Sponsor
Arkansas Children's Hospital Research Institute
Conditions
Invasive Candidiasis
Enrolling
420 people
Starts
2023-09-08
Est. completion
2032-06-30
Design
Open-label, randomized, parallel groups
Record
View on ClinicalTrials.gov ↗