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A Safety & Effectiveness Study of Intravenous Anidulafungin With AmBisome® for Treatment of Invasive Aspergillosis (IA).

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00037206
Collaborator
Vicuron Pharmaceuticals (Industry)
30
Enrollment
1
Location
9.1
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The combination of Anidulafungin plus AmBisome® may offer an improved outcome for patients treated for Invasive Aspergillosis (IA). The purpose of this study is to determine the safety and the clinical and microbiological effectiveness of anidulafungin plus AmBisome® in treated patients located in the United States, Europe, and South Africa.

Condition or Disease Intervention/Treatment Phase
  • Drug: Anidulafungin, VER002
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label Non-Comparative Study of the Safety and Efficacy of Intravenous Anidulafungin Plus AmBisome® [(Amphotericin B) Liposome for Injection] as a Treatment for Invasive Aspergillosis.
Study Start Date :
May 1, 2002
Actual Study Completion Date :
Feb 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of definite IA outside the pulmonary system or definite or probable pulmonary IA

    • Life expectancy: greater than 72 hours

    Exclusion Criteria:

    • Pregnant female

    • Hypersensitivity to anidulafungin or echinocandin therapy

    • Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid

    • Hypersensitivity to amphotericin B deoxycholate or any other constituents of AmBisome unless, in the opinion of the investigator, the benefit of therapy outweighs the risk.

    • Aspergilloma-in the absence of invasive disease

    • Abnormal blood chemistries:

    Bilirubin > 3 times the upper limit of normal; AST (aspartate aminotransferase) or ALT (alanine aminotransferase)> 5 times the upper limit of normal

    • Greater than five days of therapeutic doses of systemic therapy for the current Aspergillus-associated condition or a cumulative dose of more than 5 mg/Kg of amphotericin, more than 25 mg/Kg of a lipid formulation of amphotericin, or more than 2g of itraconazole for the current condition. Prophylactic use of azoles or amphotericin is acceptable.

    • Less than 4 weeks since prior participation in an investigational drug or device study, with the exception of cytotoxic, antiretroviral agents and therapies for AIDS-related opportunistic infections.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Versicor, Inc. King of Prussia Pennsylvania United States 19406

    Sponsors and Collaborators

    • Pfizer
    • Vicuron Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00037206
    Other Study ID Numbers:
    • VER002-7
    • A8851001
    First Posted:
    May 17, 2002
    Last Update Posted:
    Oct 21, 2008
    Last Verified:
    Oct 1, 2008
    Keywords provided by , ,
    Invasive Aspergillosis
    Additional relevant MeSH terms:
    Aspergillosis
    Anidulafungin

    Study Results

    No Results Posted as of Oct 21, 2008