A Phase 3 interventional study of Micafungin and Liposomal Amphotericin B in Candidiasis, sponsored by Astellas Pharma Inc. Completed at 37 sites in 2 countries. Per ClinicalTrials.gov, last updated 2014-09-18.
Sponsored by Astellas Pharma Inc · Phase 3, Interventional, and Treatment
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.
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.
265 studies on the registry are indexed under Candidiasis; 20 are open to participants now.
This study's enrollment of 637 is above the median of 99 across 186 interventional studies indexed under Candidiasis.
Browse Candidiasis studies →Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients either non-neutropenic with absolute neutrophil counts >= 500 cells/mm3 or neutropenic with absolute neutrophil counts \< 500 cells/mm3 must have:
Exclusion Criteria:
Drug: Micafungin
Drug: Liposomal Amphotericin B
IV
Also known as: Mycamine, FK463
IV
Also known as: AmBisome
Investigator's assessment of overall treatment success. Success is defined as clinical (complete or partial) and mycological (eradication or presumed eradication) response at the End of Therapy.
Time frame: 6 and 12 weeks post treatment
Clinical response (complete, partial, stabilization, progression) during the treatment period and the post-treatment period
Time frame: During the 2 to 8 week treatment period and the 12 week post treatment followup period
Mycological response (eradication, presumed eradication, persistence) during the treatment period and the post-treatment period
Time frame: During the 2 to 8 week treatment period and the 12 week post treatment followup period
Overall incidence of emergent and recurrent fungal infections at the End of Study
Time frame: End of the 12 week post treatment followup peroid
Independent Efficacy Review Committee's assessment of overall treatment success
Time frame: Prior to database lock
Peak change of estimated glomerular filtration rate during the treatment period compared to Baseline
Time frame: During the 2 to 8 week treatment period
Incidence of acute infusion related reactions as pre-defined
Time frame: During the 2 to 8 week treatment period
Patient survival at the End of Therapy and at the End of Study
Time frame: End of the 2 to 8 week treatment period and end of the 12 week post treatment followup period
Overall incidence of Adverse Events (AE)
Time frame: Throughout study and post treatment followup period
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Inc