A Phase II, Multicenter, Randomized, Open-label, Active Controlled Study to Evaluate the Safety and Efficacy of Micafungin Salvage Mono-therapy Versus Active Control Intravenous Salvage Mono-therapy in Patients With Invasive Aspergillosis

Descripción detallada

This is a phase II, multicentre, prospective, active-controlled, open-label, 2:1 randomised and parallel group clinical study. Patients will be stratified according to the baseline infection status and the baseline neutropenic status: * Intolerant to previous antifungal therapy * Refractory to previous antifungal therapy; progression of infection * Refractory to previous antifungal therapy; failure to improve In case, criteria for both intolerant and refractory are fulfilled at the same time the patient will be considered as refractory. * Neutropenic (absolute neutrophil count (ANC \< 500 cells/mm3) * Non neutropenic (ANC \>= 500 cells/mm3)