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Fluconazole Versus Micafungin for Candida Bloodstream Infection in Non-Neutropenic Patients
Fluconazole Versus Micafungin for Candida Bloodstream Infection in Non-Neutropenic Patients
WithdrawnPhase 4
Sponsor: Kyoto University
Conditions: Candidiasis, Sepsis
Interventions: Fluconazole, Micafungin
Countries: Japan
The purpose of this study is to verify the equivalence in clinical efficacy of fluconazole and micafungin for the treatment of Candida bloodstream infection in non-neutropenic patients.
Eligibility overview
Sex: ALL
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
Locations (1)
- Kyoto, Japan