Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive Candidiasis

Completed · Phase 4

Conditions studied: Candidiasis

In brief

The purpose of this study is to further evaluate the safety and effectiveness of intravenous anidulafungin (Eraxis™) in patients with a diagnosis of candidemia or invasive candidiasis, which is a fungus infection of the blood or tissue. Currently the drug is approved for treatment using a daily dose of IV medication until 14 days after the fungus disappears from the blood. This study will evaluate the effectiveness of intravenous anidulafungin when it is administered for 5-28 days followed by oral antifungal medication. Study patients will be assessed for response to treatment throughout the study drug treatment period.

Key facts

Study ID

NCT00496197

Run by

Pfizer

People needed

282

Starts

2007-07-01

Expected to finish

2010-06-01

Last updated by the study team

2011-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects > or equal to 18 years of age.
• Presence of candidemia (positive blood culture) or invasive candidiasis (histopathologic or cytopathologic examination of a needle aspiration or biopsy specimen from a normally sterile site excluding mucous membranes showing yeast cells) obtained within the prior 96 hours of the screening visit.
• Subjects who received no more than one prior dose of an echinocandin or polyene.

You may not qualify if…

• Subjects with hypersensitivity to anidulafungin, other echinocandins or azoles.
• Presence of confirmed or suspected Candida osteomyelitis, endocarditis or meningitis.
• Subjects with infected prosthetic devices which cannot be removed within 24 hours

Where it is running

• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — San Francisco, California, United States
• Pfizer Investigational Site — San Francisco, California, United States
• Pfizer Investigational Site — Newark, Delaware, United States
• Pfizer Investigational Site — Newark, Delaware, United States
• Pfizer Investigational Site — Wilmington, Delaware, United States
• Pfizer Investigational Site — Washington D.C., District of Columbia, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Orlando, Florida, United States
• Pfizer Investigational Site — Orlando, Florida, United States
• Pfizer Investigational Site — Orlando, Florida, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Springfield, Illinois, United States
• Pfizer Investigational Site — Springfield, Illinois, United States
• Pfizer Investigational Site — Springfield, Illinois, United States
• Pfizer Investigational Site — Springfield, Illinois, United States
• Pfizer Investigational Site — Baltimore, Maryland, United States
• Pfizer Investigational Site — Baltimore, Maryland, United States
• Pfizer Investigational Site — Detroit, Michigan, United States
• Pfizer Investigational Site — Detroit, Michigan, United States
• Pfizer Investigational Site — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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