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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Anidulafungin; Echinocandins; Fluconazole; Voriconazole

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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