Fluconazole Versus Micafungin for Candida Bloodstream Infection in Non-Neutropenic Patients

• Status: Withdrawn
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyoto University
• Collaborators: Astellas Pharma Inc; Pfizer
• Treatments: Echinocandins; Fluconazole; Micafungin

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.