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NCT00056381 Clinical Trial

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

Neutropenia Clinical Trial

Official title:
Phase I/II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Fever and Neutropenia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00056381
Other study ID # VER002-12
Secondary ID A8851005
Status Completed
Phase Phase 1/Phase 2
First received March 11, 2003
Last updated October 17, 2008
Start date July 2003
Est. completion date June 2004

Study information
Verified date October 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date June 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 17 Years
Eligibility - 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Anidulafungin

Locations
Country Name City State
United States Versicor King of Prussia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Pfizer Vicuron Pharmaceuticals

Country where clinical trial is conducted

United States, 

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