Fluconazole Versus Micafungin for Candida Bloodstream Infection in Non-Neutropenic Patients
Candidiasis, Sepsis
About this trial
This is an interventional treatment trial for Candidiasis focused on measuring Candida, bloodstream infection, fluconazole, micafungin, randomized controlled trial
Eligibility Criteria
Inclusion Criteria: Patients in whom Candida species have been isolated from blood culture. Patients accompanied by systemic infectious symptoms during the period from 24 hours (h) before collection of blood culture showing a positive result. Patients aged 20 years or older on the date of registration. Patients who have not received systemic administration of antifungal agents or who have started such administration within 48 h. Patients in whom a central venous (CV) catheter has been removed during the period from 24 h before collection of blood culture showing a positive result to registration, or a CV catheter can be removed within 72 h after registration. Patients with no verified undrainable abscess with a diameter of at least 3 cm, or impassable occlusive lesions, which are possibly attributable to Candida species. Patients from whom written informed consent to participate in this study has been obtained (or from their legally acceptable representatives). Patients who have adequate neutrophil count and hepatic/renal function in the blood test performed within 72 h before registration. Exclusion Criteria: Patients with a history of adverse reactions associated with fluconazole or micafungin. Patients who have been treated with fluconazole or micafungin for at least 1 week within 12 weeks. Patients with a history of detection of fluconazole non-susceptible Candida species within 12 weeks. Patients in whom the neutrophil count is predicted to decrease to below 500/mL. Patients who are not treated with terfenadine, triazolam, cisapride, and ergotamine, which are contraindicated for concomitant use with fluconazole. Patients who are determined to be ineligible by the investigator.
Sites / Locations
- Department of Clinical Laboratory Medicine, Kyoto University Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
1
2