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Micafungin Salvage Mono-therapy in Invasive Aspergillosis

2014-07-23 21:35:20 | BioPortfolio

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

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

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Invasive Aspergillosis

Intervention

Micafungin, Systemic antifungal therapy

Location

Buenos Aires
Argentina
9300

Status

Terminated

Source

Astellas Pharma Inc

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:35:20-0400

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