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Micafungin Salvage Mono-therapy in Invasive Aspergillosis

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Terminated
CT.gov ID
NCT00376337
Collaborator
(none)
17
Enrollment
48
Locations
2
Arms
27
Duration (Months)
0.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed 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

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Jun 1, 2006
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

infusion for 3-12 weeks

Drug: Systemic antifungal therapy
IV
Experimental: 2

infusion for 3-12 weeks

Drug: Micafungin
IV
Other Names:
  • FK463

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Overall success at end of treatment [Weeks 3-12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Buenos Aires Argentina
    2 La Plata Argentina
    3 Aalst Belgium 9300
    4 Bruxelles Belgium
    5 Gent Belgium
    6 Leuven Belgium 3000
    7 Belo Horizonte Brazil
    8 Campinas Brazil
    9 Curitiba Brazil
    10 Goiania Brazil
    11 Ipatinga Brazil
    12 Porto Alegre Brazil
    13 Ribeirao Preto Brazil
    14 Rio de Janeiro Brazil
    15 Santo Andre Brazil
    16 Sao Paolo Brazil
    17 Sao Paulo Brazil
    18 Bogota Colombia
    19 Bucaramanga Colombia
    20 Cali Colombia
    21 Rijeka Croatia
    22 Zagreb Croatia
    23 Hradec Kralove Czech Republic
    24 Olomouc Czech Republic 77520
    25 Praha Czech Republic 12820
    26 Praha Czech Republic
    27 Bobigny France
    28 Dijon France 21034
    29 Dijon France
    30 Paris Cedex 10 France
    31 Paris Cedex France
    32 Pessac Cedex France
    33 Berlin Germany
    34 Bonn Germany
    35 Munich Germany
    36 Munster Germany
    37 Wuerzburg Germany
    38 Budapest Hungary
    39 Monza Italy
    40 Pavia Italy
    41 Rozzano Italy
    42 Krakow Poland
    43 Lodz Poland
    44 Poznan Poland
    45 Madrid Spain 28034
    46 Madrid Spain 28046
    47 Salamanca Spain
    48 Sevilla Spain

    Sponsors and Collaborators

    • Astellas Pharma Inc

    Investigators

    • Study Director: Central Contact, Astellas Pharma Europe B.V.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT00376337
    Other Study ID Numbers:
    • FG463-21-20
    First Posted:
    Sep 14, 2006
    Last Update Posted:
    Sep 5, 2013
    Last Verified:
    Oct 1, 2011
    Keywords provided by Astellas Pharma Inc
    Invasive Aspergillosis
    Salvage Therapy
    Micafungin
    Additional relevant MeSH terms:
    Aspergillosis
    Micafungin
    Antifungal Agents
    Clotrimazole
    Miconazole

    Study Results

    No Results Posted as of Sep 5, 2013