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Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
Recruiting
Trial ID: NCT00413218
Purpose
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.
Official Title
A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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
Intervention(s):
drug: Isavuconazole
drug: Caspofungin
drug: Voriconazole
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Physician Referrals
650-723-0822