NCT05763251 Comparison of Uncomplicated Candidemia Therapy Duration in Children
| NCT ID | NCT05763251 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Arkansas Children's Hospital Research Institute |
| Condition | Invasive Candidiasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2023-09-08 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 420 participants in total. It began in 2023-09-08 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
Brian Fisher, DO
PRINCIPAL INVESTIGATOR
Children's Hospital of Philadelphia
Frequently Asked Questions
Who can join the NCT05763251 clinical trial?
This trial is open to participants of all sexes, aged 120 Days or older, studying Invasive Candidiasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05763251 currently recruiting?
Yes, NCT05763251 is actively recruiting participants. Contact the research team at skjohnson@uams.edu for enrollment information.
Where is the NCT05763251 trial being conducted?
This trial is being conducted at Birmingham, United States, Little Rock, United States, Orange, United States, New Haven, United States and 11 additional locations.
Who is sponsoring the NCT05763251 clinical trial?
NCT05763251 is sponsored by Arkansas Children's Hospital Research Institute. The principal investigator is Brian Fisher, DO at Children's Hospital of Philadelphia. The trial plans to enroll 420 participants.