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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01176058
First received: August 3, 2010
Last updated: October 6, 2015
Last verified: August 2015
  Purpose
In the treatment of patients with candidemia and/or other forms of invasive candidiasis , Anidulafungin is at least as effective and safe as Fluconazole.

Condition Intervention Phase
Candidemia
Drug: Anidulafungin/Fluconazole
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT) [ Time Frame: End of Intravenous Treatment (Up to Day 42) ] [ Designated as safety issue: No ]

    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:
  • Percentage of Participants With Global Response at End of Treatment (EOT) [ Time Frame: End of Treatment (Up to Day 42) ] [ Designated as safety issue: No ]

    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 [ Time Frame: End of Intravenous Treatment (Up to Day 42) ] [ Designated as safety issue: No ]
    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 [ Time Frame: End of Treatment (Up to Day 42) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Post treatment follow-up visit (Up to Day 52) ] [ Designated as safety issue: No ]
    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 [ Time Frame: End of Intravenous Treatment (Up to Day 42) ] [ Designated as safety issue: No ]
    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 [ Time Frame: End of Treatment (Up to Day 42) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Post treatment follow-up visit (Up to Day 52) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Day 52 ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: December 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: open label 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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176058

Locations
China, Guangdong
Nanfang Hospital
Guangzhou, Guangdong, China, 510515
China, Jiangsu
Nanjing General Hospital of Nanjing Military Command/Respiratory Department
Nanjing, Jiangsu, China, 210002
China, Shanghai
Changhai Hospital, Hemotology Department
Shanghai, Shanghai, China, 200433
China, Zhejiang
The First Affiliated Hospital of Medical School of Zhejiang University/Department of Hematology
Hangzhou, Zhejiang, China, 310003
Sir run run shaw hospital, Affiliated with school of medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310016
China
Peking Union Medical College Hospital / Department of Infectious Disease
Beijing, China, 100730
Institute of Antibiotics, Hua Shan Hospital, Fudan University
Shanghai, China, 200040
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01176058     History of Changes
Other Study ID Numbers: A8851023 
Study First Received: August 3, 2010
Results First Received: October 29, 2012
Last Updated: October 6, 2015
Health Authority: China: State Food and Drug Administration (SFDA)

Keywords provided by Pfizer:
Phase 3b
Efficacy and Safety evaluation of Anidulafungin
ICC

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Invasive
Candidemia
Mycoses
Fungemia
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Fluconazole
Anidulafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors

ClinicalTrials.gov processed this record on August 25, 2016