Back to resultsA Study to Evaluate the Effectiveness of Voriconazole + Micafungin Versus Voriconazole Alone for Invasive Aspergillosis
Primary Purpose
Aspergillosis/Blood, Aspergillosis/Invasive
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
micafungin
voriconazole
Sponsored by
About this trial
This is an interventional treatment trial for Aspergillosis/Blood focused on measuring Aspergillosis/blood, micafungin, voriconazole, Aspergillus
Eligibility Criteria
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
Sites / Locations
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00423163
Brief Title
A Study to Evaluate the Effectiveness of Voriconazole + Micafungin Versus Voriconazole Alone for Invasive Aspergillosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
An alternative joint industry effort will provide information on combination versus single agent therapy for treatment of aspergillosis
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the therapeutic effectiveness of voriconazole + micafungin versus voriconazole alone as primary therapy for invasive aspergillosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspergillosis/Blood, Aspergillosis/Invasive
Keywords
Aspergillosis/blood, micafungin, voriconazole, Aspergillus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
micafungin
Intervention Type
Drug
Intervention Name(s)
voriconazole
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Fountain Valley
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Palo Alto
State/Province
California
Country
United States
City
Sacramento
State/Province
California
Country
United States
City
San Francisco
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Beech Grove
State/Province
Indiana
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Kansas City
State/Province
Kansas
Country
United States
City
Wichita
State/Province
Kansas
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Bethesda
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Charlestown
State/Province
Massachusetts
Country
United States
City
Worcester
State/Province
Massachusetts
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Grand Rapids
State/Province
Michigan
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
Rochester
State/Province
Minnesota
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Albany
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Akron
State/Province
Ohio
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Portland
State/Province
Oregon
Country
United States
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Philadelphia
State/Province
Pennsylvania
Country
United States
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Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Charlottesville
State/Province
Virginia
Country
United States
City
Fairfax
State/Province
Virginia
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Madison
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Effectiveness of Voriconazole + Micafungin Versus Voriconazole Alone for Invasive Aspergillosis
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