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 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
NCT ID:
NCT06907992
Eligibility Criteria:
Inclusion Criteria:
1. Patients ≥ 18 years of age
2. Uncomplicated candidemia (positive blood culture only). No evidence of invasive candidiasis at day 1 or until day 7.
3. Received \< 5 days of prior antifungal therapy
4. Informed Consent for randomization
5. Patients that did not consent to randomization have consented to be used as a natural history (controls) and will allow collection of available data from the medical record.
Exclusion Criteria:
1. Inadequate source control (e.g., unable to remove endovascular devices, urinary catheters).
2. Invasive candidiasis of any type (e.g., deep seated candidiasis from sources other than blood)
3. Abnormal LFTs \> 10-fold
4. Greater than 5 days of prior antifungal therapy
5. Endovascular devices that cannot be removed.
6. Immunocompromised patients (AIDS/HIV; solid organ transplant, bone marrow transplant patients, oncology patients receiving chemotherapy, neutropenic patients (ANC of \< 1,500 cells/L
7. Neutropenic at time of consent (what does this mean)
8. Break-through candidemia (people with prior candidemia who relapsed) after treatment with antifungal therapy)
9. Unable to provide informed consent from either the patient or legally authorized authority (LAR)
10. Expected mortality within 96 hours
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06907992
Study Brief:
Protocol Section:
NCT06907992