Back to resultsSafety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children Ages 2-17
Primary Purpose
Neutropenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Anidulafungin
Sponsored by
About this trial
This is an interventional treatment trial for Neutropenia focused on measuring neutropenia, fever, febrile neutropenia
Eligibility 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.
Sites / Locations
- Versicor
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00056381
First Posted
March 11, 2003
Last Updated
October 17, 2008
Sponsor
Pfizer
Collaborators
Vicuron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00056381
Brief Title
Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children Ages 2-17
Official Title
Phase I/II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Fever and Neutropenia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
Collaborators
Vicuron Pharmaceuticals
4. Oversight
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia
Keywords
neutropenia, fever, febrile neutropenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Anidulafungin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Versicor
City
King of Prussia
State/Province
Pennsylvania
ZIP/Postal Code
19406
Country
United States
12. IPD Sharing Statement
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Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children Ages 2-17
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