Conditions: Aspergillosis Invasive Fungal Infection
Keywords: Invasive fungal disease BAL8557 Isavuconazole ASP9766 Filamentous fungi Phase III Aspergillus species
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 527
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the efficacy and safety of isavuconazole versus voriconazole in the treatment of patients with invasive aspergillosis.

Detailed description:
Acute invasive fungal infections caused by aspergillus, zygomycetes and other filamentous fungi remain life threatening diseases. Early treatment with highly effective anti-fungals reduces mortality. This study investigates the efficacy and safety of isavuconazole in the treatment of invasive fungal diseases, caused by Aspergillus or other filamentous fungi.

Arms:
arm 1: Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days. arm 2: Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.

Interventions: intervention 1: Isavuconazole intervention 2: Voriconazole
Intervention descriptions: intervention 1: Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules). intervention 2: Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).

Protocol document: