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

Pfizer

Status and phase

Completed

Phase 4

Conditions

Candidiasis

Treatments

Drug: Diflucan (fluconazole)

Drug: Eraxis (anidulafungin)

Drug: Vfend (voriconazole)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00496197

A8851011

Details and patient eligibility

About

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.

Enrollment

282 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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