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Comparing antifungal treatment durations for children with uncomplicated candidemia

Short Course Versus Standard Course Antifungal Therapy for Uncomplicated Candidemia in Children and Adolescents: A Multi-Center Randomized Controlled Trial

Not applicable Interventional Arkansas Children's Hospital Research Institute · NCT05763251

This study is testing if giving children with uncomplicated candidemia an extra 7 days of antifungal treatment helps them recover better than stopping treatment after the first week.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment420 (estimated)
Ages120 Days and up
SexAll
SponsorArkansas Children's Hospital Research Institute Academic / other
Locations22 sites (Birmingham, Alabama and 21 other locations)
Trial IDNCT05763251 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of two different durations of antifungal therapy in pediatric patients diagnosed with uncomplicated candidemia. Participants will be randomized to receive either an additional 7 days of antifungal treatment or no further treatment after an initial 7 days of therapy. The study also includes an observational component that assesses the T2Candida® biomarker to evaluate its association with patient outcomes at 14 days. Eligible patients must be hospitalized children aged between 120 days and 18 years who have shown a clinical response to initial treatment and have no evidence of metastatic infection.

Who should consider this trial

Good fit: Ideal candidates are hospitalized children aged over 120 days and under 18 years with uncomplicated candidemia who have received initial antifungal therapy.

Not a fit: Patients with neutropenia or those expected to develop neutropenia during the study follow-up will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help determine the optimal duration of antifungal therapy, potentially reducing unnecessary treatment and improving patient outcomes.

How similar studies have performed: Other studies have explored antifungal therapy durations, but this specific comparison in pediatric patients is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Birmingham, Alabama and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Invasive Candidiasis
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.