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

• ClinicalTrials.gov Identifier: NCT01176058
• Recruitment Status: Terminated
• First Posted: August 5, 2010
• Results First Posted: September 21, 2015
• Last Update Posted: October 28, 2015
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Candidemia	Drug: Anidulafungin/Fluconazole	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: December 2010
• Actual Primary Completion Date: November 2011
• Actual Study Completion Date: November 2011

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT) [ Time Frame: 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 :

1. Percentage of Participants With Global Response at End of Treatment (EOT) [ Time Frame: 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.

2. Percentage of Participants With Clinical Response at EOIT [ Time Frame: 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.
3. Percentage of Participants With Clinical Response at EOT [ Time Frame: 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.
4. Percentage of Participants With Clinical Response at Follow-Up [ Time Frame: 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.
5. Percentage of Participants With Microbiological Response at EOIT [ Time Frame: 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).
6. Percentage of Participants With Microbiological Response at EOT [ Time Frame: 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).
7. Percentage of Participants With Microbiological Response at Follow-Up [ Time Frame: 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).
8. Number of Participants Who Died [ Time Frame: Baseline to Day 52 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01176058
• Other Study ID Numbers: A8851023
• First Posted: August 5, 2010
• Results First Posted: September 21, 2015
• Last Update Posted: October 28, 2015
• Last Verified: August 2015

Keywords provided by Pfizer:

Phase 3b; Efficacy and Safety evaluation of Anidulafungin; ICC

Additional relevant MeSH terms:

Candidiasis; Candidemia; Candidiasis, Invasive; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Fluconazole; Anidulafungin; 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