Clinical Trial: A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multi-center, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of Mycamine® vs Itraconazole Oral Solution for Prophylaxis of Fungal Infections in Patients
Brief Summary: The objective of this study is to compare the efficacy and safety between Mycamine and Itraconazole oral solution in preventing invasive fungal infections on autologous(malignant blood diseases) or allogeneic hematopoietic stem cell transplant patients
Detailed Summary: Dosing of Mycamine or Itraconazole will start at the beginning of the transplant conditioning regimen or within 48 hours after the transplant conditioning regimen, and administration time should be no longer than 42 days
Sponsor: Astellas Pharma Inc
Current Primary Outcome: Treatment success rate (fungal breakthrough rate) [ Time Frame: At the end of the study ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Incidence of proven or probable invasive fungal infection [ Time Frame: Throughout the study period ]
- The usage rate of systemic antifungal agents [ Time Frame: During 4 weeks after the administration ]
- Time to treatment failure [ Time Frame: During the study period ]
- Assessment of Adverse events, Laboratory examinations and vital signs evaluation [ Time Frame: Throughout the study period ]
Original Secondary Outcome: Same as current
Information By: Astellas Pharma Inc
Dates:
Date Received: November 19, 2008
Date Started: November 2008
Date Completion:
Last Updated: March 25, 2016
Last Verified: March 2016
