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 Overview
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Brief Summary
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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 Description
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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.

Official Title
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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 Other Forms Of Invasive Candidiasis

Conditions
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Candidemia

Intervention / Treatment
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* Drug: Anidulafungin/Fluconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of candidemia or invasive candidiasis. Presence of one or more of signs and symptoms of acute fungal infection. Exclusion Criteria: Subjects who received greater than 48 hours of systemic antifungal treatment for the Candida infection for which they will be enrolled. Subjects with hypersensitivity to echinocandins or azole therapy or drug excipients.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: open label<br> | Drug: Anidulafungin/Fluconazole<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | End of Intravenous Treatment (Up to Day 42) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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). | 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). | 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). | Post treatment follow-up visit (Up to Day 52) | 
| Number of Participants Who Died |  | Baseline to Day 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 3b, Efficacy and Safety evaluation of Anidulafungin, ICC