Status:
WITHDRAWN
Fluconazole Versus Micafungin for Candida Bloodstream Infection in Non-Neutropenic Patients
Lead Sponsor:
Kyoto University
Collaborating Sponsors:
Pfizer
Astellas Pharma Inc
Conditions:
Candidiasis
Sepsis
Eligibility:
All Genders
Phase:
PHASE4
Brief 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.
Detailed Description
Candida bloodstream infection occurs in patients with poor general conditions and has poor prognosis with attributable mortality of more than 30%. Clinical efficacy of fluconazole for the treatment of...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00304772
Start Date
August 1 2006
End Date
December 1 2008
Last Update
June 14 2024
Active Locations (1)
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1
Department of Clinical Laboratory Medicine, Kyoto University Hospital
Kyoto, Japan, 606-8507