Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis
Trial ID or NCT#
NCT00412893
Status
NOT RECRUITING
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.
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Wes (Janice) Brown
Blood and marrow transplant specialist,
Blood and marrow transplant specialist,
Infectious disease doctor
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Contact us to find out if this trial is right for you.
Contact
Physician Referrals
650-723-0822
View on ClinicalTrials.gov
