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

Candidemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01176058
• Other study ID #: A8851023
• Status: Terminated
• Phase: Phase 3
• First received: August 3, 2010
• Last updated: October 6, 2015
• Start date: December 2010
• Est. completion date: November 2011

Study information

• Verified date: August 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: State Food and Drug Administration (SFDA)
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Candidemia
• Candidiasis
• Candidiasis, Invasive

Intervention

Drug:
• Anidulafungin/Fluconazole
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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Number of Participants Who Died		Baseline to Day 52	Yes

External Links

•   To obtain contact information for a study center near you, click here.