Status:
COMPLETED
Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Basilea Pharmaceutica
Conditions:
Candidiasis, Invasive
Candidemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.
Detailed Description
Candida infections, representing approximately 80% of all major systemic fungal infections, are the fourth most common cause of nosocomial bloodstream infections, with a mortality rate of 40%. Isavuco...
Eligibility Criteria
Inclusion
- Patients with candidemia or with an invasive Candida infection
- Presence of fever, hypothermia or other appropriate local sign of infection
- Female patients must be non-lactating and at no risk of pregnancy
Exclusion
- Patients with a sole diagnosis of mucocutaneous candidiasis, i.e. oropharyngeal, esophageal or genital candidiasis; or candidal lower urinary tract infection or Candida isolated solely from respiratory tract specimens
- Patients with candidemia who failed a previous antifungal therapy for the same infection
- Patients previously enrolled in a phase III study with isavuconazole
- Patients with a body weight \<40kg
Key Trial Info
Start Date :
March 8 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2015
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00413218
Start Date
March 8 2007
End Date
March 3 2015
Last Update
December 10 2024
Active Locations (113)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0006
2
Somero Research Corporation
Palm Desert, California, United States, 92211
3
University of California Davis Health System
Sacramento, California, United States, 95817
4
University of California at San Francisco
San Francisco, California, United States, 94143