Comparison of Uncomplicated Candidemia Therapy Duration in Children (COUNT)
Invasive Candidiasis
About this trial
This is an interventional treatment trial for Invasive Candidiasis
Eligibility Criteria
Inclusion Criteria: Age > 120 days and < 18 years at the time of positive blood culture at any participating site; Candidemia with at least one positive blood culture for any Candida spp; Receiving/received an echinocandin (caspofungin, micafungin or anidulafungin) as primary antifungal therapy for candidemia for at least 3 days from day of first negative culture with continuation of uninterrupted systemic antifungal therapy at the time of enrollment); Sustained clearance of Candida spp. from repeat blood culture(s) obtained on or before day of randomization; Partial or complete clinical response, as defined by published guidelines, on or before day of randomization; No evidence of metastatic foci of infection at the time of randomization, as documented by a negative abdominal ultrasound or abdominal CT scan of the liver, spleen, and kidneys and negative ophthalmologic examination. Exclusion Criteria: 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
Sites / Locations
- Children's Hospital of PhiladelphiaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Short-course therapy
Standard-course therapy
pediatric patients with uncomplicated candidemia who have already received 7 days of primary systemic antifungal therapy will receive no additional antifungal therapy
pediatric patients with uncomplicated candidemia who have already received 7 days of primary systemic antifungal therapy will receive 7 additional days of systemic antifungal therapy