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This study has been withdrawn prior to enrollment.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)
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00423163
First received: January 17, 2007
Last updated: June 18, 2007
Last verified: June 2007
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Estimated Enrollment: 350
Study Start Date: February 2007
  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423163

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

No publications provided

ClinicalTrials.gov Identifier: NCT00423163     History of Changes
Other Study ID Numbers: 20-05-002
Study First Received: January 17, 2007
Last Updated: June 18, 2007
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Aspergillosis
Mycoses
Voriconazole
Micafungin
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 10, 2014