A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of BAL8557 Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi.

CompletadoFase 3ClinicalTrials.gov

ID: NCT00412893Tipo: INTERVENTIONALInicio: 7 de mar de 2007Fin estimado: 28 de mar de 2013

Traducción no disponible, mostrando original

Resumen

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

Descripción detallada

Acute invasive fungal infections caused by aspergillus, zygomycetes and other filamentous fungi remain life threatening diseases. Early treatment with highly effective anti-fungals reduces mortality. This study investigates the efficacy and safety of isavuconazole in the treatment of invasive fungal diseases, caused by Aspergillus or other filamentous fungi.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

Patients with invasive fungal infections other than Aspergillus species or other filamentous fungi
Evidence of hepatic dysfunction at Baseline or moderate to severe renal dysfunction
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 \</= 40 kg

Intervenciones

drug

Isavuconazole

Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).

drug

Voriconazole

Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).

Ubicaciones

Buenos Aires, Argentina

Capital Federal, Argentina

Hospital Italiano de Buenos Aires

Ciudad Autonoma, Argentina

Instituto Medico Especializado Alexander Fleming

Ciudad Autonoma, Argentina

Patrocinadores

PrincipalAstellas Pharma Inc

ColaboradorBasilea Pharmaceutica International Ltd

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