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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00423163 |
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Date of registration:
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17/01/2007 |
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Primary sponsor: |
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Public title:
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A Study to Evaluate the Effectiveness of Voriconazole + Micafungin Versus Voriconazole Alone for Invasive Aspergillosis
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Scientific title:
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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 |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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350 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT00423163 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Use Central Contact |
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Address:
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Telephone:
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Email:
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Affiliation:
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Astellas Pharma US, Inc. |
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Key inclusion & exclusion criteria
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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
Age minimum:
2 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Aspergillosis/Blood
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Aspergillosis/Invasive
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Intervention(s)
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Drug: micafungin
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Drug: voriconazole
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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
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Secondary ID(s)
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20-05-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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