Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis

Astellas

Status and phase: Completed; Phase 3

Conditions: Invasive Fungal Infection; Aspergillosis

Treatments: Drug: Voriconazole; Drug: Isavuconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00412893

WSA-CS-004 (Other Identifier)

9766-CL-0104

2006-003868-59 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 527 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 </= 40 kg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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527 participants in 2 patient groups

Isavuconazole

Experimental group

Description:

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.

Treatment:

Drug: Isavuconazole

Voriconazole

Active Comparator group

Description:

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.

Treatment:

Drug: Voriconazole