NCT00304772

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

A Randomized Comparative Study of Fluconazole Versus Micafungin for the Treatment of Candida Bloodstream Infection in Non-Neutropenic Patients

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Kyoto University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 Candida bloodstream infection has been reported in clinical studies, since 1985 when it placed on the market. Fluconazole has established a position as the first-line drug up to date. However, possibly associated with the increased use of fluconazole, increased frequency of Candida species or strains with low susceptibility to fluconazole has been pointed out. Micafungin, an antifungal echinocandin with a different antifungal mechanism from fluconazole, has been reported to show good in vitro activity to various Candida species and strains with fluconazole resistance, and has comparative clinical efficacy with fluconazole for esophageal candidiasis, while it has relatively low in vitro activity to certain Candida species. There is no comparative study of fluconazole versus micafungin against Candida bloodstream infection.

Conditions

• Candidiasis
• Sepsis

Interventions

Type	Name	Description
DRUG	Fluconazole	400mg/day
DRUG	Micafungin	150mg/day

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2006-03-20
• Last updated: 2024-06-14

Locations

1 site across 1 country: Japan