Clincosm LogoSign in Get a demo

Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children Ages 2-17

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00056381
Collaborator
Vicuron Pharmaceuticals (Industry)
25
Enrollment
1
Location
11
Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Anidulafungin is a medicine being developed for treatment of adults with certain kinds of fungal infections. This study is evaluating anidulafungin in children and adolescents who have fever and a low white blood cell count (neutropenia).

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

Anidulafungin is an investigational drug being developed as an intravenous treatment for esophageal candidiasis, candidemia and other invasive fungal infections. Anidulafungin is an antifungal agent of the echinocandin class, which targets the fungal cell wall of yeast and other filamentous fungi.

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I/II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Fever and Neutropenia
Study Start Date :
Jul 1, 2003
Actual Study Completion Date :
Jun 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    • Children ages 2-17 years with fever and neutropenia.

    • The expected duration of neutropenia should be 10 days and due to cytotoxic chemotherapy or aplastic anemia.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Versicor 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:
    NCT00056381
    Other Study ID Numbers:
    • VER002-12
    • A8851005
    First Posted:
    Mar 12, 2003
    Last Update Posted:
    Oct 21, 2008
    Last Verified:
    Oct 1, 2008
    Keywords provided by , ,
    neutropenia
    fever
    febrile neutropenia
    Additional relevant MeSH terms:
    Neutropenia
    Anidulafungin

    Study Results

    No Results Posted as of Oct 21, 2008