Comparison of Uncomplicated Candidemia Therapy Duration in Children

Recruiting now · Not applicable

Conditions studied: Invasive Candidiasis

In brief

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.

Key facts

Study ID

NCT05763251

Run by

Arkansas Children's Hospital Research Institute

People needed

420

Starts

2023-09-08

Expected to finish

2032-06-30

Last updated by the study team

2026-04-17

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 120 days at the time of the first negative blood culture at any participating site;
• Candidemia with at least one positive blood culture for any Candida spp;
• 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);
• Sustained clearance of Candida spp. defined as negative blood culture(s) obtained after onset of candidemia and before day of randomization;
• Partial or complete clinical response, as defined by published guidelines (Table 5), on or before day of randomization;
• 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.

You may not qualify if…

• Already receiving antifungal therapy for a previously diagnosed systemic invasive fungal disease;
• Neutropenic (absolute neutrophil count < 500 cells/µl) at the time of enrollment or anticipated to be neutropenic in the week following randomization;
• Have an underlying condition that requires them to be on antifungal prophylaxis when not receiving directed therapy for an invasive fungal disease;
• Previous enrollment in this trial;
• Females of childbearing age with a current pregnancy diagnosis or without a negative pregnancy test for their current admission;
• A documented DNR order;
• Have an implantable cardiac device (e.g., ventricular assist device, pacemaker)

Where it is running

• Children's Hospital of Alabama — Birmingham, Alabama, United States (enrolling)
• Arkansas Children's Hospital — Little Rock, Arkansas, United States (enrolling)
• Children's Hospital of Orange County — Orange, California, United States (enrolling)
• Yale New Haven Children's Hospital — New Haven, Connecticut, United States (enrolling)
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States (enrolling)
• Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
• Comer Children's Hospital — Chicago, Illinois, United States (enrolling)
• Riley Children's Hospital — Indianapolis, Indiana, United States (enrolling)
• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• CS Mott Children's Hospital — Ann Arbor, Michigan, United States (enrolling)
• Washington University St. Louis — St Louis, Missouri, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• Weill Cornell Medical College — New York, New York, United States (enrolling)
• Duke Children's Hospital — Durham, North Carolina, United States (enrolling)
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States (enrolling)
• Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Dell Children's Medical Center — Austin, Texas, United States (enrolling)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Primary Children's Hospital — Salt Lake City, Utah, United States (enrolling)
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
• Perth Children's Hospital — Perth, Western Australia, Australia (enrolling)

Full record on ClinicalTrials.gov

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