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

History of Changes

Tracking Information
First Received Date ^ICMJE	March 11, 2003
Last Updated Date	October 17, 2008
Start Date ^ICMJE	July 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00056381 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children Ages 2-17
Official Title ^ICMJE	Phase I/II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Fever and Neutropenia
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).
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 Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Neutropenia
Intervention ^ICMJE	Drug: Anidulafungin
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	25
Completion Date	June 2004
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	2 Years to 17 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00056381
Other Study ID Numbers ^ICMJE	VER002-12, A8851005
Has Data Monitoring Committee	Not Provided
Responsible Party	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor ^ICMJE	Pfizer
Collaborators ^ICMJE	Vicuron Pharmaceuticals
Investigators ^ICMJE	Not Provided
Information Provided By	Pfizer
Verification Date	October 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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