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

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.

Intervention(s) in this Clinical Trial

• Drug: Eraxis (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.
• Drug: Diflucan (fluconazole)
  • 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.
• Drug: Vfend (voriconazole)
  • 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: 1.
  • Subjects receive anidulafungin IV followed by oral therapy with fluconazole or voriconazole.

Primary Measures

• Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT)
  • Time Frame: End of Treatment (Day 5 up to Day 42)
    Safety Issue?: No

Secondary Measures

• Number of Participants With Clinical Response at EOT
  • Time Frame: End of Treatment (Day 5 up to Day 42)
    Safety Issue?: No
• Number of Participants With Microbiological Response at EOT
  • Time Frame: End of Treatment (Day 5 up to Day 42)
    Safety Issue?: No
• Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Intravenous Treatment (EOIV)
  • Time Frame: End of Intravenous treatment (Day 5 up to Day 28)
    Safety Issue?: No
• Number of Participants With Clinical Response at EOIV
  • Time Frame: End of Intravenous treatment (Day 5 up to Day 28)
    Safety Issue?: No
• Number of Participants With Microbiological Response at EOIV
  • Time Frame: End of Intravenous treatment (Day 5 up to Day 28)
    Safety Issue?: No
• Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up
  • Time Frame: Week 2 Follow-up
    Safety Issue?: No
• Number of Participants With Sustained (Continued) Clinical Response at Week 2 Follow-up
  • Time Frame: Week 2 follow-up
    Safety Issue?: No
• Number of Participants With Sustained (Continued) Microbiological Response at Week 2 Follow-up
  • Time Frame: Week 2 Follow-up
    Safety Issue?: No
• Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (End of Study [EOS])
  • Time Frame: Week 6 Follow-up (EOS)
    Safety Issue?: No
• Number of Participants With Sustained (Continued) Clinical Response at Week 6 Follow-up (EOS)
  • Time Frame: Week 6 follow-up (EOS)
    Safety Issue?: No
• Number of Participants With Sustained (Continued) Microbiological Response at Week 6 Follow-up (EOS)
  • Time Frame: Week 6 Follow-up (EOS)
    Safety Issue?: No
• Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOT for Participants With Non-albicans Candida at Baseline
  • Time Frame: End of Treatment (Day 5 up to Day 42)
    Safety Issue?: No
• Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOIV for Participants With Non-albicans Candida at Baseline
  • Time Frame: End of Intravenous treatment (Day 5 up to Day 28)
    Safety Issue?: No
• Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up for Participants With Non-albicans Candida at Baseline
  • Time Frame: Week 2 Follow-up
    Safety Issue?: No
• Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (EOS) for Participants With Non-albicans Candida at Baseline
  • Time Frame: Week 6 Follow-up (EOS)
    Safety Issue?: No
• Time (75% Quartile Point Estimate) to Negative Blood and / or Tissue Culture for Candida Species
  • Time Frame: Baseline (Day 1) up to Week 6 Follow-up (EOS)
    Safety Issue?: No
• Medical Resource Utilization (MRU): Duration of Hospital Stay (Days)
  • Time Frame: Baseline up to 6 Week Follow-up (EOS)
    Safety Issue?: No
• Medical Resource Utilization (MRU): Duration of Intensive Care Unit or Critical Care Unit Stay (Days)
  • Time Frame: Baseline up to 6 Week Follow-up (EOS)
    Safety Issue?: No
• Medical Resource Utilization (MRU): Duration of Intravenous Therapy (Days)
  • Time Frame: Baseline up to End of Intravenous treatment (Day 5 up to Day 28)
    Safety Issue?: No
• Medical Resource Utilization (MRU): Duration of Overall Therapy (Days)
  • Time Frame: Baseline up to End of Treatment (Day 5 up to Day 42)
    Safety Issue?: No
• Number of Participants Per Specified Cause of Death
  • Time Frame: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)
    Safety Issue?: Yes
• Number of Participants With Non-serious and Serious Adverse Events
  • Time Frame: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)
    Safety Issue?: Yes
• Number of Participants Who Died
  • Time Frame: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)
    Safety Issue?: Yes

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 Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

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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