Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis

• Conditions: Invasive fungal disease caused by Aspergillus species or other filamentous fungi.; MedDRA version: 14.1Level: PTClassification code 10003488Term: AspergillosisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2006-003868-59-DE
• Lead Sponsor: Astellas Pharma Global Development, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-16
• Last Update Posted: 29 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 510

Inclusion Criteria

•Patients must have probable or proven invasive fungal disease caused by Aspergillus species or other filamentous fungi
•Female patients must be non-lactating and at no risk for pregnancy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients with invasive fungal infections other than Aspergillus species or other filamentous fungi
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified