Isavuconazole for Primary Treatment of Invasive Aspergillosis - Full Text View

Sponsored by:	Basilea Pharmaceutica
Information provided by:	Basilea Pharmaceutica
ClinicalTrials.gov Identifier:	NCT00412893

Purpose

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

Condition	Intervention	Phase
Invasive Fungal Infection Aspergillosis	Drug: Isavuconazole Drug: Voriconazole	Phase III

MedlinePlus related topics: Fungal Infections Molds

Drug Information available for: Voriconazole

U.S. FDA Resources

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

Further study details as provided by Basilea Pharmaceutica:

Primary Outcome Measures:

Overall outcome (clinical, mycological and radiological response)

Secondary Outcome Measures:

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

Estimated Enrollment:	360
Study Start Date:	December 2006

Arms	Assigned Interventions
1: Experimental Isavuconazole	Drug: Isavuconazole Drug treatment
2: Experimental Voriconazole	Drug: Voriconazole Drug treatment

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412893

Contacts

Contact: Markus Heep, MD

41-616-061 ext 316

markus.heep@basilea.com

Show 145 Study Locations

Sponsors and Collaborators

Basilea Pharmaceutica

Investigators

Study Director:

Markus Heep, MD

Basilea Pharmaceutica

More Information

Responsible Party:	Basilea Pharmaceutica ( Markus Heep, MD )
Study ID Numbers:	WSA-CS-004
Study First Received:	December 18, 2006
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00412893
Health Authority:	United States: Food and Drug Administration; European Union: European Medicines Agency; Australia: National Health and Medical Research Council

Keywords provided by Basilea Pharmaceutica:

Phase III
Invasive fungal disease
Aspergillus species
Filamentous fungi

Study placed in the following topic categories:

Mycoses
Clotrimazole
Miconazole

Voriconazole
Tioconazole
Aspergillosis

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antifungal Agents
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009