Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106288
Status:
COMPLETED
Last Update Posted:
2014-09-18
First Post:
2005-03-22
Brief Title:
Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Multicenter Double Blind Comparative Randomized Study to Evaluate the Efficacy and Safety of Micafungin FK463 Versus Liposomal Amphotericin B AmBisome in the Treatment of Invasive Candidiasis and 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 this study is to determine the efficacy and safety of micafungin FK463 versus liposomal amphotericin B AmBisome in treating neutropenic and non-neutropenic patients with confirmed invasive candidiasis or candidemia Enrollment will include adult and pediatric patients
Detailed Description:
A phase III multicenter double-blind comparative parallel randomized study Enrollment will include adult and pediatric patients The adult population is sized to test for non-inferiority For the pediatric population descriptive analyses are planned
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