Clinical trial NCT01176058: 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
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 Other Forms Of Invasive Candidiasis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Candidemia
Keywords: Phase 3b
Efficacy and Safety evaluation of Anidulafungin
ICC
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-08-05
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT)
timeFrame: End of Intravenous Treatment (Up to Day 42)
Secondary outcomes:
measure: Percentage of Participants With Global Response at End of Treatment (EOT)
timeFrame: End of Treatment (Up to Day 42)
measure: Percentage of Participants With Clinical Response at EOIT
timeFrame: End of Intravenous Treatment (Up to Day 42)
measure: Percentage of Participants With Clinical Response at EOT
timeFrame: End of Treatment (Up to Day 42)
measure: Percentage of Participants With Clinical Response at Follow-Up
timeFrame: Post treatment follow-up visit (Up to Day 52)
measure: Percentage of Participants With Microbiological Response at EOIT
timeFrame: End of Intravenous Treatment (Up to Day 42)
measure: Percentage of Participants With Microbiological Response at EOT
timeFrame: End of Treatment (Up to Day 42)
measure: Percentage of Participants With Microbiological Response at Follow-Up
timeFrame: Post treatment follow-up visit (Up to Day 52)
measure: Number of Participants Who Died
timeFrame: Baseline to Day 52
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
city: Nanjing
country: China
facility: Nanjing General Hospital of Nanjing Military Command/Respiratory Department
state: Jiangsu
city: Shanghai
country: China
facility: Changhai Hospital, Hemotology Department
state: Shanghai
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Medical School of Zhejiang University/Department of Hematology
state: Zhejiang
city: Hangzhou
country: China
facility: Sir run run shaw hospital, Affiliated with school of medicine, Zhejiang University
state: Zhejiang
city: Beijing
country: China
facility: Peking Union Medical College Hospital / Department of Infectious Disease
city: Shanghai
country: China
facility: Institute of Antibiotics, Hua Shan Hospital, Fudan University
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: