Micafungin Salvage Mono-therapy in Invasive Aspergillosis

Status Terminated

Clinical Trial Summary

To evaluate the efficacy and safety of micafungin in patients with proven invasive aspergillosis and who are refractory or intolerant to previous systemic antifungal therapy. To compare the efficacy and safety of the micafungin therapy with the active control arm

Clinical Trial Description

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) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00376337
Study type	Interventional
Source	Astellas Pharma Inc
Contact
Status	Terminated
Phase	Phase 2
Start date	June 2006
Completion date	September 2008

View Details

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