Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive Candidiasis

Last updated: August 29, 2011
Sponsor: Pfizer
Overall Status: Completed

Phase

4

Condition

Gynecological Infections

Yeast Infections

Systemic Candidiasis

Treatment

N/A

Clinical Study ID

NCT00496197
A8851011
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to further evaluate the safety and effectiveness of intravenous anidulafungin (Eraxis™) in patients with a diagnosis of candidemia or invasive candidiasis, which is a fungus infection of the blood or tissue. Currently the drug is approved for treatment using a daily dose of IV medication until 14 days after the fungus disappears from the blood. This study will evaluate the effectiveness of intravenous anidulafungin when it is administered for 5-28 days followed by oral antifungal medication. Study patients will be assessed for response to treatment throughout the study drug treatment period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female subjects > or equal to 18 years of age.

  • Presence of candidemia (positive blood culture) or invasive candidiasis (histopathologic or cytopathologic examination of a needle aspiration or biopsyspecimen from a normally sterile site excluding mucous membranes showing yeast cells)obtained within the prior 96 hours of the screening visit.

  • Subjects who received no more than one prior dose of an echinocandin or polyene.

Exclusion

Exclusion Criteria:

  • Subjects with hypersensitivity to anidulafungin, other echinocandins or azoles.

  • Presence of confirmed or suspected Candida osteomyelitis, endocarditis or meningitis.

  • Subjects with infected prosthetic devices which cannot be removed within 24 hours

Study Design

Total Participants: 282
Study Start date:
July 01, 2007
Estimated Completion Date:
June 30, 2010

Connect with a study center

  • Pfizer Investigational Site

    Seoul, 137-701
    Korea, Republic of

    Site Not Available

  • Pfizer Investigational Site

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Pfizer Investigational Site

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Pfizer Investigational Site

    Los Angeles, California 90033
    United States

    Site Not Available

  • Pfizer Investigational Site

    San Francisco, California 94143
    United States

    Site Not Available

  • Pfizer Investigational Site

    Newark, Delaware 19713
    United States

    Site Not Available

  • Pfizer Investigational Site

    Wilmington, Delaware 19801
    United States

    Site Not Available

  • Pfizer Investigational Site

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Pfizer Investigational Site

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Pfizer Investigational Site

    Miami, Florida 33136
    United States

    Site Not Available

  • Pfizer Investigational Site

    Orlando, Florida 32801
    United States

    Site Not Available

  • Pfizer Investigational Site

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Pfizer Investigational Site

    Springfield, Illinois 62701
    United States

    Site Not Available

  • Pfizer Investigational Site

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Pfizer Investigational Site

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Pfizer Investigational Site

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • Pfizer Investigational Site

    Minnesota, Minnesota 55455
    United States

    Site Not Available

  • Pfizer Investigational Site

    Butte, Montana 59701
    United States

    Site Not Available

  • Pfizer Investigational Site

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Pfizer Investigational Site

    Albany, New York 12208
    United States

    Site Not Available

  • Pfizer Investigational Site

    Buffalo, New York 14263
    United States

    Site Not Available

  • Pfizer Investigational Site

    Rochester, New York 14642
    United States

    Site Not Available

  • Pfizer Investigational Site

    Greenville, North Carolina 27834-6028
    United States

    Site Not Available

  • Pfizer Investigational Site

    Portland, Oregon 97239
    United States

    Site Not Available

  • Pfizer Investigational Site

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Pfizer Investigational Site

    West Reading, Pennsylvania 19611
    United States

    Site Not Available

  • Pfizer Investigational Site

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Pfizer Investigational Site

    Houston, Texas 77030
    United States

    Site Not Available

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