Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis

Active, not recruiting

• Conditions: Invasive fungal disease caused by Aspergillus species or other filamentous fungi.; MedDRA version: 15.1Level: PTClassification code 10003488Term: AspergillosisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-22
• Last Update Posted: 29 April 2013

Recruitment & Eligibility

• Status: Not 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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To compare the effects of treatment on:<br>- All Cause mortality rate at Day 84.<br>- Overall outcome at Day 42, end of treatment (EOT) and Day 84<br>- Overall outcome at Day 42, end of treatment (EOT) and Day 84<br>in patients with mycologically confirmed lower respiratory tract disease (LRTD)<br>- Overall outcome and mycological response at Day 42, EOT and Day 84 in the subpopulations defined by the stratification variables<br>- Mycological response at Day 42, EOT and Day 84<br>- To characterize the safety and tolerance of treatment with isavuconazole<br>;Main Objective: To compare all cause mortality through Day 42 following primary treatment with isavuconazole versus voriconazole (VRC) in patients with IFD caused by Aspergillus species or other filamentous fungi.;Primary end point(s): All cause mortality through Day 42.;Timepoint(s) of evaluation of this end point: Time Frame: Up to Day 42