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

This study has been completed.
Vicuron Pharmaceuticals
Information provided by:
Pfizer Identifier:
First received: March 11, 2003
Last updated: October 17, 2008
Last verified: October 2008
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 Intervention Phase
Drug: Anidulafungin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Enrollment: 25
Study Start Date: July 2003
Study Completion Date: June 2004
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.

Ages Eligible for Study:   2 Years to 17 Years   (Child)
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
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Please refer to this study by its identifier: NCT00056381

United States, Pennsylvania
King of Prussia, Pennsylvania, United States, 19406
Sponsors and Collaborators
Vicuron Pharmaceuticals
  More Information

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00056381     History of Changes
Other Study ID Numbers: VER002-12
Study First Received: March 11, 2003
Last Updated: October 17, 2008

Keywords provided by Pfizer:
febrile neutropenia

Additional relevant MeSH terms:
Leukocyte Disorders
Hematologic Diseases
Antifungal Agents
Anti-Infective Agents processed this record on May 25, 2017