Official Title: “Open-Label, Non-Comparative, Study Of Intravenous Anidulafungin, Followed Optionally By Oral Voriconazole Or Fluconazole Therapy, For Treatment Of Documented Candidemia/Invasive Candidiasis In Intensive Care Unit Patient Populations”

To evaluate the efficacy and safety of anidulfungin in the treatment of systemic fungal infections in intensive care and critical care unit patients.

Study Type: Interventional

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

Study Primary Completion Date: March 2010

Intervention(s) in this Clinical Trial

• Drug: Fluconazole
  • Oral Administration of Fluconazole
• Drug: Anidulafungin
  • Anidulafungin Intravenous Administration
• Drug: Voriconazole
  • Oral Administration of Voriconazole

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Treatment Group
  • Option to treat with oral azole therapy following treatment with anidulfungin

Primary Measures

• The primary efficacy endpoint will be the global treatment response at the End of Treatment.
  • Time Frame: up to 56 days
    Safety Issue?: No

Secondary Measures

• Global response at the End of Intra Venous Treatment, at 2 weeks after End of Treatment and at 6 weeks after End of Treatment.
  • Time Frame: up to 14 weeks
    Safety Issue?: No
• Time to first negative blood/tissue culture (defined as first negative culture which is not followed by positive culture within the next 3 days).
  • Time Frame: up to 56 days
    Safety Issue?: No
• Day 90 survival
  • Time Frame: up to 100 days
    Safety Issue?: No
• Time to ICU discharge.
  • Time Frame: up to 56 days
    Safety Issue?: No
• Incidence of adverse events and discontinuation from study treatment.
  • Time Frame: up to 56 days
    Safety Issue?: No

Inclusion Criteria:

• ICU patients with a diagnosis of documented candidemia or invasive candidiasis and belonging to one or more of the following specific populations:
• Post-abdominal surgery.
• Elderly > 65 years old.
• Renal insufficiency / failure / hemodialysis.
• Solid tumor.
• Solid-organ (liver, kidney, lung, heart) transplant recipients.
• Hepatic insufficiency.
• Neutropenic including hematology oncology patients.

Exclusion Criteria:

• Patients with poor venous access that would preclude IV drug delivery or multiple blood draws.

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 August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00689338

Study ID Number: A8851019

ClinicalTrials.gov Identifier: NCT00689338

Health Authority: United Kingdom: Department of Health

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