Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

• Status: Completed
• Trial end date: 2002-01-27
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the safety and efficacy of FK463 in the treatment of patients with confirmed candidemia or invasive candidiasis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Micafungin

Criteria

Inclusion Criteria

• Has Candidemia or invasive candidiasis documented by typical clinical signs and symptoms and confirmed by fungal culture or histologic confirmation

Exclusion Criteria

• Has abnormal liver test parameters, e.g., AST or ALT > 10 times upper limit of normal

• Has life expectancy judged to be less than 5 days

• De novo patients who have received a systemic antifungal agent for the treatment of this episode of candidemia or invasive candidiasis for more than 48 hours prior to the first dose of FK463; or efficacy failure patients who have received =< 5 days of prior systemic antifungal therapy for the treatment of this episode of candidemia or invasive candidiasis

• Require treatment with topical or systemic antifungal agents for conditions other than candidemia or invasive candidiasis