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

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ClinicalTrials.gov 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Recruitment Status : Withdrawn (An alternative joint industry effort will provide information on combination versus single agent therapy for treatment of aspergillosis)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
Sponsor:
Information provided by:

Study Description
Brief Summary:
To evaluate the therapeutic effectiveness of voriconazole + micafungin versus voriconazole alone as primary therapy for invasive aspergillosis.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00423163


  Show 44 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma US, Inc.
More Information

ClinicalTrials.gov Identifier: NCT00423163     History of Changes
Other Study ID Numbers: 20-05-002
First Posted: January 18, 2007    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015

Keywords provided by Astellas Pharma Inc:
Aspergillosis/blood
micafungin
voriconazole
Aspergillus

Additional relevant MeSH terms:
Aspergillosis
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Voriconazole
Micafungin
Echinocandins
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