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A Study to Evaluate the Effectiveness of Voriconazole + Micafungin Versus Voriconazole Alone for Invasive Aspergillosis

This study has been withdrawn prior to enrollment.
(An alternative joint industry effort will provide information on combination versus single agent therapy for treatment of aspergillosis)
Information provided by:
Astellas Pharma Inc Identifier:
First received: January 17, 2007
Last updated: August 31, 2015
Last verified: August 2015
To evaluate the therapeutic effectiveness of voriconazole + micafungin versus voriconazole alone as primary therapy for invasive aspergillosis.

Condition Intervention Phase
Aspergillosis/Blood Aspergillosis/Invasive Drug: micafungin Drug: voriconazole Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • The primary outcome will be Global Success (complete and partial response) at 6 weeks based on the combination of clinical, mycological and radiologic response.

Secondary Outcome Measures:
  • 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

Enrollment: 0
Study Start Date: February 2007

Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00423163

  Show 44 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Use Central Contact Astellas Pharma US, Inc.
  More Information Identifier: NCT00423163     History of Changes
Other Study ID Numbers: 20-05-002
Study First Received: January 17, 2007
Last Updated: August 31, 2015

Keywords provided by Astellas Pharma Inc:

Additional relevant MeSH terms:
Skin Diseases, Infectious
Skin Diseases
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors processed this record on August 21, 2017