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Comparison of Uncomplicated Candidemia Therapy Duration in Children

RecruitingNAAges 120 Days - anyAllArkansas Children's Hospital Research Institute
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In plain words

What the trial is, and whether it could suit you

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 th

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age \> 120 days at the time of the first negative blood culture at any participating site; 2. Candidemia with at least one positive blood culture for any Candida spp; 3. Receiving/received an echinocandin (caspofungin, micafungin, anidulafungin, or rezafungin) 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. defined as negative blood culture(s) obtained after onset of candidemia and before day of randomization; 5. Partial or complete clinical response, as defined by published guidelines (Table 5), on or before day of randomization; 6. Between the onset of qualifying candidemia and randomization, no suspicion of disseminated candidiasis by patient's clinical team or, if deemed clinically necessary, documented negative radiological imaging such as an abdominal ultrasound or abdominal CT scan. Exclusion Criteria: 1. Already receiving antifungal therapy for a previously diagnosed systemic invasive fungal disease; 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)
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What it tests

  • therapy duration
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Where

22 sites
Children's Hospital of Alabama
Birmingham, United States
Arkansas Children's Hospital
Little Rock, United States
Children's Hospital of Orange County
Orange, United States
Yale New Haven Children's Hospital
New Haven, United States
Children's Healthcare of Atlanta
Atlanta, United States
Lurie Children's Hospital of Chicago
Chicago, United States
Comer Children's Hospital
Chicago, United States
Riley Children's Hospital
Indianapolis, United States

…and 14 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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