Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304772
Status:
WITHDRAWN
Last Update Posted:
2024-06-14
First Post:
2006-03-17
Brief Title:
Fluconazole Versus Micafungin for Candida Bloodstream Infection in Non-Neutropenic Patients
Sponsor:
Kyoto University
Organization:
Kyoto University
Study Overview
Official Title:
A Randomized Comparative Study of Fluconazole Versus Micafungin for the Treatment of Candida Bloodstream Infection in Non-Neutropenic Patients
Status:
WITHDRAWN
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Subjects were not recruited as intended
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None