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
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
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.
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%. Isavuconazole is not yet approved for the treatment of fungal infections. This study investigates the efficacy and safety of intravenous and oral isavuconazole. Patients are randomized to isavuconazole and the reference regimen. Patients with a positive blood- or deep tissue culture of candida fungi can be included.
Inclusion Criteria:
Exclusion Criteria:
Capital Federal, C1280AEB, Argentina
Capital Federal, C1405DCS, Argentina
Ciudad Autonoma, 1181, Argentina
Ciudad Autonoma, 1426, Argentina
Puente Alto Santiago, Chile
Noida, National Capital Territory of Delhi 201301, India
Vellore Tamilnadu, India
Petah, 49100, Israel
Lyttelton Centurion, 0157, South Africa
Bangkoknoi, 10700, Thailand
Muang, 30000, Thailand
Muang, 40002, Thailand
Muang, 50200, Thailand