In the treatment of patients with candidemia and/or other forms of invasive candidiasis , Anidulafungin is at least as effective and safe as Fluconazole.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
17
Anidulafungin:IV,100 mg daily preceded by an initial 200 mg dose on Day 1, 14 - 42 days Fluconazole: IV/Oral, 400mg,QD,14 - 42 days
Nanfang Hospital
Guangzhou, Guangdong, China
Nanjing General Hospital of Nanjing Military Command/Respiratory Department
Nanjing, Jiangsu, China
Changhai Hospital, Hemotology Department
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Medical School of Zhejiang University/Department of Hematology
Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT)
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 not available \[N/A\] for a participant with a successful clinical response). Failure - Any case that did not meet the criteria for success.
Time frame: End of Intravenous Treatment (Up to Day 42)
Percentage of Participants With Global Response at End of Treatment (EOT)
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.
Time frame: End of Treatment (Up to Day 42)
Percentage of Participants With Clinical Response at EOIT
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.
Time frame: End of Intravenous Treatment (Up to Day 42)
Percentage of Participants With Clinical Response at EOT
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.
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Hangzhou, Zhejiang, China
Sir run run shaw hospital, Affiliated with school of medicine, Zhejiang University
Hangzhou, Zhejiang, China
Peking Union Medical College Hospital / Department of Infectious Disease
Beijing, China
Institute of Antibiotics, Hua Shan Hospital, Fudan University
Shanghai, China
Time frame: End of Treatment (Up to Day 42)
Percentage of Participants With Clinical Response at Follow-Up
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.
Time frame: Post treatment follow-up visit (Up to Day 52)
Percentage of Participants With Microbiological Response at EOIT
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).
Time frame: End of Intravenous Treatment (Up to Day 42)
Percentage of Participants With Microbiological Response at EOT
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).
Time frame: End of Treatment (Up to Day 42)
Percentage of Participants With Microbiological Response at Follow-Up
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).
Time frame: Post treatment follow-up visit (Up to Day 52)
Number of Participants Who Died
Time frame: Baseline to Day 52