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

This study has been completed.

First Received: March 11, 2003 Last Updated: October 17, 2008 History of Changes

Sponsor:	Pfizer
Collaborator:	Vicuron Pharmaceuticals
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00056381

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Fever

Drug Information available for: Anidulafungin

U.S. FDA Resources

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

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

Additional Information:

Link to ClinicalStudyResults.org Posting' This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Pfizer:

neutropenia
fever
febrile neutropenia

Additional relevant MeSH terms:

Anti-Infective Agents
Neutropenia
Echinocandins
Hematologic Diseases
Therapeutic Uses
Antifungal Agents

Antibiotics, Antifungal
Agranulocytosis
Leukocyte Disorders
Leukopenia
Pharmacologic Actions
Anidulafungin

ClinicalTrials.gov processed this record on November 27, 2009