An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Deep Tissue Infection Due To Candida

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Candidiasis, Fungemia

In brief

The purpose of this study is to gather information on the use of anidulafungin for the treatment of serious Candida infection. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.

Key facts

Study ID

NCT00805740

Run by

Pfizer

People needed

41

Starts

2009-04-01

Expected to finish

2012-06-01

Last updated by the study team

2013-08-01

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of deep tissue Candida infection, defined as growth of Candida sp. from a culture specimen obtained from a normally sterile site accompanied by signs and symptoms of infection.
• Male or female ≥ 16 years of age.
• Expected hospitalization for at least fourteen (14) days.

You may not qualify if…

• Pregnancy or breast feeding or planning to become pregnant during the study.
• Recent treatment with one of the study drugs over the last 30 days.
• Allergy to either study drug or to this class of drugs.
• Significant liver dysfunction.
• Suspected Candida osteomyelitis, endocarditis, meningitis or any other infections of the central nervous system.

Where it is running

• Pfizer Investigational Site — Newark, Delaware, United States
• Pfizer Investigational Site — Newark, Delaware, United States
• Pfizer Investigational Site — Wilmington, Delaware, United States
• Pfizer Investigational Site — Detroit, Michigan, United States
• Pfizer Investigational Site — Antwerp, Belgium
• Pfizer Investigational Site — Brussels, Belgium
• Pfizer Investigational Site — Brussels, Belgium
• Pfizer Investigational Site — Brussels, Belgium
• Pfizer Investigational Site — Sofia, Bulgaria
• Pfizer Investigational Site — Vancouver, British Columbia, Canada
• Pfizer Investigational Site — Amsterdam, Netherlands
• Pfizer Investigational Site — Amsterdam, Netherlands
• Pfizer Investigational Site — Nijmegen, Netherlands
• Pfizer Investigational Site — Coimbra, Portugal
• Pfizer Investigational Site — Lisbon, Portugal
• Pfizer Investigational Site — Bucharest, Romania
• Pfizer Investigational Site — P/o Stepanovskoe, Krasnogorskiy District, Moscow Region, Russia
• Pfizer Investigational Site — Geneva, Switzerland

Full record on ClinicalTrials.gov

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