Comparison of Uncomplicated Candidemia Therapy Duration in Children

Launched by ARKANSAS CHILDREN'S HOSPITAL RESEARCH INSTITUTE · Mar 8, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how long children with uncomplicated candidemia (a type of fungal infection in the bloodstream) should continue antifungal treatment. Specifically, it compares two groups: one group will receive an additional 7 days of antifungal therapy after already being treated for a week, while the other group will stop treatment after the first week. The goal is to find out if stopping the treatment earlier is just as effective as continuing it longer.

To participate, children aged 120 days to 18 years must have a positive blood culture for Candida and have been on antifungal therapy for at least 3 days. They should also show signs of improvement and have no signs of severe infection in other parts of their body. If eligible, parents will be asked to consent for their child to be part of the study, which will involve random selection into one of the two treatment groups. This trial is currently recruiting participants, and it aims to help doctors determine the best treatment duration for children with this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age \> 120 days and \< 18 years at the time of positive 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 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);
• • 4. Sustained clearance of Candida spp. from repeat blood culture(s) obtained on or before day of randomization;
• • 5. Partial or complete clinical response, as defined by published guidelines, on or before day of randomization;
• • 6. 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:
• • 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)