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Comparison of Uncomplicated Candidemia Therapy Duration in Children

Study acronym: COUNT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 17 to 22 Eligibility criteria expanded, about 7 wordsv7 Show 1 more changeShow less
    • Eligibility criteria expanded, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 11 to 17 Eligibility criteria expanded, about 14 wordsv6 Show 1 more changeShow less
    • Eligibility criteria expanded, about 14 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 5 to 11 Collaborators: 4 to 5v5 Show 1 more changeShow less
    • Collaborators: 4 to 5

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  4. Primary completion date: Jan 1, 2029 to Jun 30, 2030 Completion date: Jun 30, 2029 to Jun 30, 2032 · Start date: Sep 1, 2023 to Sep 8, 2023v4 Show 2 more changesShow less
    • Completion date: Jun 30, 2029 to Jun 30, 2032
    • Start date: Sep 1, 2023 to Sep 8, 2023
  5. Study sites: 1 to 5v3
  6. Trial status: Not Yet Recruiting to Recruiting Start date: Mar 1, 2023 to Sep 1, 2023 · Enrollment target: 400 to 420 · Study sites: 0 to 1 · 2 morev2 Show 5 more changesShow less
    • Start date: Mar 1, 2023 to Sep 1, 2023
    • Enrollment target: 400 to 420
    • Study sites: 0 to 1
    • Primary completion date: Jan 31, 2029 to Jan 1, 2029
    • Completion date: Jul 31, 2029 to Jun 30, 2029
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov