Conditions: Aspergillosis Invasive Fungal Infections
Keywords: invasive fungal infections caused by rare molds, rare yeasts BAL8557 Isavuconazole Aspergillosis or by dimorphic fungi ASP9766
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 149
Healthy volunteers: no

Brief summary:
The purpose of this study is to investigate the efficacy and safety of isavuconazole in the treatment of renally impaired participants with invasive fungal infections caused by Aspergillus and participants with invasive fungal disease caused by rare fungi.

Detailed description:
Acute invasive fungal infections caused by aspergillus, rare moulds, yeasts or dimorphic fungi are life threatening diseases. Early treatment with highly effective anti-fungals reduces mortality. This study investigates the safety and efficacy of isavuconazole in participants with aspergillosis and renal impairment, and in participants suffering from invasive infections from rare fungi.

Arms:
arm 1: Administration of isavuconazole 3 times a day in the vein (IV) or oral as a capsule for 2 days followed by daily administration of isavuconazole (IV) or oral

Interventions: intervention 1: isavuconazole
Intervention descriptions: intervention 1: Administration of 200 mg isavuconazole 3 times a day in the vein (IV) or oral as a capsule for 2 days, followed by daily administration of 200 mg isavuconazole (IV) or oral

Protocol document: