A Study to Evaluate the Effectiveness of Voriconazole + Micafungin Versus Voriconazole Alone for 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: NCT00423163
Recruitment Status : Withdrawn (An alternative joint industry effort will provide information on combination versus single agent therapy for treatment of aspergillosis)
First Posted : January 18, 2007
Last Update Posted : September 2, 2015
Information provided by:
Astellas Pharma Inc

January 17, 2007
January 18, 2007
September 2, 2015
February 2007
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The primary outcome will be Global Success (complete and partial response) at 6 weeks based on the combination of clinical, mycological and radiologic response.
Same as current
Complete list of historical versions of study NCT00423163 on Archive Site
Global Success (GS) at Wk 12, Favorable response (FR) & survival at Wks 6 & 12. GS and FR by infection site, overall frequency of emergent & recurrent fungal infections at Wks 6 & 12, duration of FR, and relationship of galactomannan to clinical outcome
Same as current
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A Study to Evaluate the Effectiveness of Voriconazole + Micafungin Versus Voriconazole Alone for Invasive Aspergillosis
A Double-Blind, Randomized Controlled Trial of Voriconazole (VFEND®) Plus Micafungin (MYCAMINE™) Versus Voriconazole Plus Placebo in the Treatment of Patients With Proven or Probable Invasive Aspergillosis
To evaluate the therapeutic effectiveness of voriconazole + micafungin versus voriconazole alone as primary therapy for invasive aspergillosis.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Aspergillosis/Blood
  • Aspergillosis/Invasive
  • Drug: micafungin
  • Drug: voriconazole
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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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Inclusion Criteria:

  • Proven, probable or possible invasive aspergillosis
  • Patient is 2 years of age or older

Exclusion Criteria:

  • The patient has been administered an antifungal agent (voriconazole, itraconazole, posaconazole, caspofungin, micafungin, anidulafungin, amphotericin B, or lipid formulation of amphotericin B) for >7 days immediately prior to randomization for treatment of the Possible, Probable, or Proven invasive aspergillosis for which the patient is being enrolled.
  • The patient has been treated with voriconazole for > 7 days immediately prior to randomization
Sexes Eligible for Study: All
2 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Astellas Pharma Inc
Not Provided
Study Director: Use Central Contact Astellas Pharma US, Inc.
Astellas Pharma Inc
August 2015

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