Official Title: “A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of Isavuconazole Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi.”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

Acute invasive fungal infections caused by aspergillus, zygomycetes and other filamentous fungi remain to be a life threatening diseases. Early treatment with highly effective anti-fungals reduces mortality. Isavuconazole is not yet registered for the treatment of fungal infections. This study investigates the efficacy and safety of isavuconazole in the treatment of invasive fungal diseases, caused by Aspergillus or other filamentous fungi.

Patients are randomized to receive either isavuconazole or voriconazole. The study compares the safety and efficacy of both drugs.

Intervention(s) in this Clinical Trial

• Drug: Isavuconazole
  • Drug treatment
• Drug: Voriconazole
  • Drug treatment

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Isavuconazole
• Experimental: 2
  • Voriconazole

Primary Measures

• Overall outcome (clinical, mycological and radiological response)

Secondary Measures

• Overall outcome at different time points and in predefined sub-populations
• Mycological response
• Survival rate

Inclusion Criteria:

• Patients must have probable or proven invasive fungal disease caused by Aspergillus species or other filamentous fungi

Exclusion Criteria:

• Patients with invasive fungal infections other than Aspergillus species or other filamentous fungi
• Patients with either chronic aspergillosis or aspergilloma
• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Basilea Pharmaceutica

Overall Clinical Trial Officials and Contacts

Markus Heep, MD Study Director Basilea Pharmaceutica  

Overall Contact: Markus Heep, MD 41-616-061 markus.heep@basilea.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00412893

Study ID Number: WSA-CS-004

ClinicalTrials.gov Identifier: NCT00412893

Health Authority: United States: Food and Drug Administration