Study Stopped
An alternative joint industry effort will provide information on combination versus single agent therapy for treatment of aspergillosis
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
1 other identifier
interventional
N/A
1 country
44
Brief Summary
To evaluate the therapeutic effectiveness of voriconazole + micafungin versus voriconazole alone as primary therapy for invasive aspergillosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2007
CompletedFirst Posted
Study publicly available on registry
January 18, 2007
CompletedStudy Start
First participant enrolled
February 1, 2007
CompletedSeptember 2, 2015
August 1, 2015
January 17, 2007
August 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- Proven, probable or possible invasive aspergillosis
- Patient is 2 years of age or older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Fountain Valley, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Palo Alto, California, United States
Unknown Facility
Sacramento, California, United States
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San Francisco, California, United States
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Denver, Colorado, United States
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Washington D.C., District of Columbia, United States
Unknown Facility
Miami, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Beech Grove, Indiana, United States
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Indianapolis, Indiana, United States
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Kansas City, Kansas, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Boston, Massachusetts, United States
Unknown Facility
Charlestown, Massachusetts, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Omaha, Nebraska, United States
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Albany, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Winston-Salem, North Carolina, United States
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Charlottesville, Virginia, United States
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Fairfax, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Madison, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Use Central Contact
Astellas Pharma US, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 17, 2007
First Posted
January 18, 2007
Study Start
February 1, 2007
Last Updated
September 2, 2015
Record last verified: 2015-08