Status:
TERMINATED
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
Lead Sponsor:
Pfizer
Conditions:
Candidemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 re...
Eligibility Criteria
Inclusion
- Presence of candidemia or invasive candidiasis.
- Presence of one or more of signs and symptoms of acute fungal infection.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01176058
Start Date
December 1 2010
End Date
November 1 2011
Last Update
October 28 2015
Active Locations (7)
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1
Nanfang Hospital
Guangzhou, Guangdong, China, 510515
2
Nanjing General Hospital of Nanjing Military Command/Respiratory Department
Nanjing, Jiangsu, China, 210002
3
Changhai Hospital, Hemotology Department
Shanghai, Shanghai Municipality, China, 200433
4
The First Affiliated Hospital of Medical School of Zhejiang University/Department of Hematology
Hangzhou, Zhejiang, China, 310003