NCT00794703

A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections

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 Undergoing a Hematopoietic Stem Cell Transplant

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 description

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

Conditions

• Fungemia
• Fungal Infections

Interventions

Type	Name	Description
DRUG	micafungin (Mycamine)	Intravenous
DRUG	itraconazole	oral

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2008-11-20
• Last updated: 2016-03-28

Locations

10 sites across 1 country: China