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

Phase 3

Terminated

Conditions: Candidemia

Interventions: Drug: Anidulafungin/Fluconazole

Registration Number: NCT01176058

Lead Sponsor: Pfizer

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 Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 17

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
open label	Anidulafungin/Fluconazole	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT)	End of Intravenous 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 not available \[N/A\] for a participant with a successful clinical response). Failure - Any case that did not meet the criteria for success.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Global Response at End of Treatment (EOT)	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	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	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	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	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	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	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	Baseline to Day 52

Trial Locations

Locations (7): Changhai Hospital, Hemotology Department
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Shanghai, Shanghai, China
The First Affiliated Hospital of Medical School of Zhejiang University/Department of Hematology
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Hangzhou, Zhejiang, China
Nanfang Hospital
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Guangzhou, Guangdong, China
Nanjing General Hospital of Nanjing Military Command/Respiratory Department
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Nanjing, Jiangsu, China
Sir run run shaw hospital, Affiliated with school of medicine, Zhejiang University
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Hangzhou, Zhejiang, China
Institute of Antibiotics, Hua Shan Hospital, Fudan University
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Shanghai, China
Peking Union Medical College Hospital / Department of Infectious Disease
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Beijing, China