Official Title: “Phase IV Open Label Non Comparative Trial Of IV Anidulafungin Followed By Oral Azole Therapy For The Treatment Of Candidemia And Invasive Candidiasis”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2009

Intervention(s) in this Clinical Trial

• Drug: anidulafungin
  • Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: anidulafungin
  • Subjects receive anidulafungin IV followed by oral therapy with fluconazole or voriconazole.

Primary Measures

• The primary efficacy endpoint will be a global response consisting of a combination of clinical and microbiological responses. The clinical response will be assessed by the investigator at the End of Treatment (EOT) visit.
  • Time Frame: 6 weeks after end of therapy
    Safety Issue?: No

Secondary Measures

• Global response rate at the End of IV Treatment (EOIV) as well as the Week 2 and Week 6 week follow up visits. Time to negative blood/tissue culture. Evaluation of Medical Resource Utilization with the use of data collection for predefined data points.
  • Time Frame: Up to 6 weeks after end of therapy
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00496197

Study ID Number: A8851011

ClinicalTrials.gov Identifier: NCT00496197

Health Authority: United States: Food and Drug Administration

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