Tracking Information
Start Date ICMJE | December 2006 |
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Primary Completion Date | |
Current Primary Outcome Measures ICMJE (submitted: December 18, 2006) | Overall outcome (clinical, mycological and radiological response) |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00412893 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: December 18, 2006) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Isavuconazole for Primary Treatment of Invasive Aspergillosis |
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Official Title ICMJE | 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. |
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 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. |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
Condition ICMJE |
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Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 360 | ||||
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Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Egypt, France, Germany, Hungary, India, Israel, Italy, Korea, Republic of, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Peru, Philippines, Poland, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Thailand, Turkey |
Administrative Information
NCT ID ICMJE | NCT00412893 | ||||
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Responsible Party | Markus Heep, MD, Basilea Pharmaceutica | ||||
Study ID Numbers ICMJE | WSA-CS-004 | ||||
Study Sponsor ICMJE | Basilea Pharmaceutica | ||||
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Investigators ICMJE |
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Information Provided By | Basilea Pharmaceutica |