Clinical Trial: A Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole In The Treatment Of Patients With Candidemia And/Or Other Forms Of Invasive Candidiasis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase Iiib, Open-label, Randomized, Multi-center Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole, In The Treatment Of Subjects With Candidemia And/or O

Brief Summary: In the treatment of patients with candidemia and/or other forms of invasive candidiasis , Anidulafungin is at least as effective and safe as Fluconazole.

Detailed Summary: To support anidulafungin NDA in China Due to the challenges in subject recruitment resulting in protracted study course, Pfizer Inc. has decided to terminate trial A8851023 prematurely based on the recommendation by the senior management team on November 8, 2011. The decision to terminate the trial was not based on any safety concerns. All investigators were verbally informed by the study team since November 8, 2011 to stop the subject recruitment as soon as possible. All 17 enrolled subjects have been followed up on safety issues and no safety concerns were present by the data of these subjects.
Sponsor: Pfizer

Current Primary Outcome: Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT) [ Time Frame: End of Intravenous Treatment (Up to Day 42) ]

Original Primary Outcome: The primary endpoint is Global Response (combined clinical and microbiological response) at End of Intravenous Treatment (EOIT) in subjects with confirmed candidemia and/or other forms of invasive candidiasis. [ Time Frame: End of Intravenous Treatment (EOIT) ]

Current Secondary Outcome:

• Percentage of Participants With Global Response at End of Treatment (EOT) [ Time Frame: End of Treatment (Up to Day 42) ]

  Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were N/A for a participant with a successful clinical response).

  Failure - Any case that did not meet the criteria for success.

• Percentage of Participants With Clinical Response at EOIT [ Time Frame: End of Intravenous Treatment (Up to Day 42) ]
  Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.
• Percentage of Participants With Clinical Response at EOT [ Time Frame: End of Treatment (Up to Day 42) ]
  Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.
• Percentage of Participants With Clinical Response at Follow-Up [ Time Frame: Post treatment follow-up visit (Up to Day 52) ]
  Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.
• Percentage of Participants With Microbiological Response at EOIT [ Time Frame: End of Intravenous Treatment (Up to Day 42) ]
  Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).
• Percentage of Participants With Microbiological Response at EOT [ Time Frame: End of Treatment (Up to Day 42) ]
  Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).
• Percentage of Participants With Microbiological Response at Follow-Up [ Time Frame: Post treatment follow-up visit (Up to Day 52) ]
  Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).
• Number of Participants Who Died [ Time Frame: Baseline to Day 52 ]

Original Secondary Outcome:

• Global response at the end of all study treatment (intravenous and oral). [ Time Frame: the end of all study treatment ]
• Clinical response at EOIT, EOT and follow-up visit [ Time Frame: EOIT,EOT, follow-up visit ]
• Microbiological response at EOIT, EOT and follow-up visit [ Time Frame: EOIT,EOT, follow-up visit ]
• Mortality [ Time Frame: the end of study ]
• Safety and tolerability of anidulafungin and fluconazole including adverse events and laboratory tests. [ Time Frame: during study ]

Dates:
Date Received: August 3, 2010
Date Started: December 2010
Date Completion:
Last Updated: October 6, 2015
Last Verified: August 2015