Micafungin Salvage Mono-therapy in Invasive Aspergillosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00376337
Recruitment Status : Terminated (Study was stopped due to difficulties in recruitment and changes in standard care for invasive aspergillosis)
First Posted : September 14, 2006
Last Update Posted : September 5, 2013
Information provided by (Responsible Party):
Astellas Pharma Inc

September 13, 2006
September 14, 2006
September 5, 2013
June 2006
September 2008   (Final data collection date for primary outcome measure)
Independent Data Review Board (IDRB) assessment of the overall success at the End of Treatment (EoT) defined as complete or partial clinical response. [ Time Frame: Weeks 3-12 ]
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Complete list of historical versions of study NCT00376337 on Archive Site
Overall success at end of treatment [ Time Frame: Weeks 3-12 ]
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Micafungin Salvage Mono-therapy in Invasive Aspergillosis
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
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

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)
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Invasive Aspergillosis
  • Drug: Micafungin
    Other Name: FK463
  • Drug: Systemic antifungal therapy
  • Active Comparator: 1
    infusion for 3-12 weeks
    Intervention: Drug: Systemic antifungal therapy
  • Experimental: 2
    infusion for 3-12 weeks
    Intervention: Drug: Micafungin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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September 2008
September 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Argentina,   Belgium,   Brazil,   Colombia,   Croatia,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Poland,   Spain
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Astellas Pharma Inc
Astellas Pharma Inc
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Study Director: Central Contact Astellas Pharma Europe B.V.
Astellas Pharma Inc
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP