Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT05763251
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
120 Days
Maximum Age:
18 Years
Study:
NCT05763251
Study Brief:
Protocol Section:
NCT05763251