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Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis
Not Recruiting
Trial ID: NCT00412893
Purpose
The purpose of this study is to compare the efficacy and safety of isavuconazole versus
voriconazole in the treatment of patients with invasive aspergillosis.
Official Title
A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of BAL8557 Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi.
Stanford Investigator(s)
Wes (Janice) Brown
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Eligibility
Inclusion Criteria:
- Patients must have proven, probable or possible invasive fungal disease caused by
Aspergillus species or other filamentous fungi
- Female patients must be non-lactating and at no risk for pregnancy
Exclusion Criteria:
- Patients with invasive fungal infections other than Aspergillus species or other
filamentous fungi
- Evidence of hepatic dysfunction at Baseline or moderate to severe renal dysfunction
- Patients with chronic aspergillosis, or aspergilloma or allergic bronchopulmonary
aspergillosis
- Patients who have received more than 4 days of systemic antifungal therapy other than
fluconazole within the 7 days prior to the first administration of study medication
- Patients previously enrolled in a Phase III study with isavuconazole
- Patients with a body weight
Intervention(s):
drug: Isavuconazole
drug: Voriconazole
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Physician Referrals
650-723-0822