Micafungin Salvage Mono-therapy in Invasive Aspergillosis

Study Overview
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Brief Summary
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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

Detailed Description
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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)

Official Title
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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

Conditions
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Invasive Aspergillosis

Intervention / Treatment
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* Drug: Micafungin
* Drug: Systemic antifungal therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with HSCT, acute leukaemia or myelodysplastic syndrome, with proven (probable only in case of pulmonary aspergillosis) invasive aspergillosis and refractory or intolerant to amphotericin B or voriconazole products Exclusion Criteria: Patients with allergic bronchopulmonary aspergillosis, chronic pulmonary aspergillosis, aspergilloma, sinus aspergillosis or external otitis; patient with previous salvage therapy for the current episode of fungal infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>infusion for 3-12 weeks | Drug: Systemic antifungal therapy<br>* IV<br>|
| Experimental: 2<br>infusion for 3-12 weeks | Drug: Micafungin<br>* IV<br>* Other names: FK463;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Independent Data Review Board (IDRB) assessment of the overall success at the End of Treatment (EoT) defined as complete or partial clinical response. |  | Weeks 3-12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall success at end of treatment |  | Weeks 3-12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Invasive Aspergillosis, Salvage Therapy, Micafungin