Candidemia
Conditions
Keywords
candidemia, uncomplicated candidemia, antifungal therapy, echinocandin, caspofungin, micafungin, rezafungin, anidulafungin
Brief summary
The goal of this clinical trial is to assess whether a seven-day course of standard of care (echinocandin) antifungal therapy is non-inferior to a 14-day course of echinocandin antifungal therapy in patients with uncomplicated candidemia in terms of clinical, mycologic, adverse events and all cause mortality.
Interventions
Short-course antifungal therapy (7 days) versus standard of care antifungal therapy (14 days)
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication of candida from the blood at day 7 or day 14 | 14 Days | Blood culture monitoring at day 7 and day 14 |
Countries
United States