Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105144
Status:
COMPLETED
Last Update Posted:
2014-09-18
First Post:
2005-03-07
Brief Title:
Study of Micafungin in Patients With Invasive Candidiasis or Candidemia
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Comparative Study of Micafungin FK463 Versus Caspofungin as Antifungal Treatment in Patients With Invasive Candidiasis or Candidemia
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determine the safety and effectiveness of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia
Detailed Description:
The purpose of the study is to determine the efficacy and safety of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia The maximum length of antifungal treatment is 4 weeks except in pre-defined patients where maximum length of therapy is 8 weeks A post treatment assessment will be conducted at 2 weeks and 6 weeks after the last dose of all antifungal treatments
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