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

This study has been completed.
Sponsor:
Collaborator:
Vicuron Pharmaceuticals
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00056381
First received: March 11, 2003
Last updated: October 17, 2008
Last verified: October 2008
  Purpose

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
Neutropenia
Drug: Anidulafungin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056381

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

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00056381     History of Changes
Other Study ID Numbers: VER002-12, A8851005
Study First Received: March 11, 2003
Last Updated: October 17, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
neutropenia
fever
febrile neutropenia

Additional relevant MeSH terms:
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Anidulafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014