Comparison of Uncomplicated Candidemia Therapy Duration in Children

Study Status: Recruiting

The primary objective of this study will be addressed with a multi-center open label randomized controlled trial designed to 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. The secondary objective of this study is an embedded observational biomarker study. This objective will determine if the novel T2Candida® biomarker performed at the time of randomization (i.e. Day 7 of systemic antifungal therapy) will be associated with patient outcomes assessed at Day 14. The results of the T2Candida® biomarker will not be available in real-time and thus will not impact the primary study objective. Eligible patients will be any hospitalized patient at a participating center with uncomplicated candidemia that is older than 120 days and <18 years of age at time of candidemia onset. Patients need to receive an echinocandin as their primary antifungal therapy for at least three days and continue systemic antifungal therapy (either with an echinocandin or step-down to an azole) for a total of 7 days from their first negative blood culture and have no evidence of metastatic foci of candidemia at the time of randomization. Patients with neutropenia or anticipated to have neutropenia during the study follow-up window will not be eligible. Patients can only be enrolled to the study once. This study population will serve as the source cohort for both study objectives. Patients will be randomized 1:1 to one of two study arms, short-course therapy or standard-course therapy. Patients will be followed for 21 days from the day of randomization (Day 7 to Day 28) to capture primary and secondary outcome measures.

Sex: ALL
Minimum Age: 120 Days
Maximum Age: 18 Years

Researchers look for people who fit a certain description, called eligibility criteria. Below are the inclusion and exclusion criteria for study participants:

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 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. 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
A documented DNR order
Have an implantable cardiac device (e.g., ventricular assist device, pacemaker)

Conditions

Invasive Candidiasis

Intervention/Treatment

OTHER : therapy duration

Sponsor

Arkansas Children's Hospital Research Institute

Principal Investigator(s)

Brian Fisher, DO, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia
William J Steinbach, MD, PRINCIPAL_INVESTIGATOR, Arkansas Children's Hospital Research Institute