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

August 31, 2015 updated by: Astellas Pharma Inc

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

To evaluate the therapeutic effectiveness of voriconazole + micafungin versus voriconazole alone as primary therapy for invasive aspergillosis.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • California
      • Fountain Valley, California, United States
      • Los Angeles, California, United States
      • Palo Alto, California, United States
      • Sacramento, California, United States
      • San Francisco, California, United States
    • Colorado
      • Denver, Colorado, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Miami, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Beech Grove, Indiana, United States
      • Indianapolis, Indiana, United States
    • Kansas
      • Kansas City, Kansas, United States
      • Wichita, Kansas, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Bethesda, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Charlestown, Massachusetts, United States
      • Worcester, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Detroit, Michigan, United States
      • Grand Rapids, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
      • Rochester, Minnesota, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New York
      • Albany, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Akron, Ohio, United States
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Charlottesville, Virginia, United States
      • Fairfax, Virginia, United States
      • Richmond, Virginia, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Study Registration Dates

First Submitted

January 17, 2007

First Submitted That Met QC Criteria

January 17, 2007

First Posted (Estimate)

January 18, 2007

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-05-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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