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:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01176058
First received: August 3, 2010
Last updated: January 12, 2012
Last verified: January 2012
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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 3b, Open-Label, Randomized, Multi-Center Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole In The Treatment Of Patients With Candidemia And/Or Other Forms Of Invasive Candidiasis |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- The primary endpoint is Global Response (combined clinical and microbiological response) at End of Intravenous Treatment (EOIT) in subjects with confirmed candidemia and/or other forms of invasive candidiasis. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Global response at the end of all study treatment (intravenous and oral). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Clinical response at EOIT, EOT and follow-up visit [ Time Frame: 7 days, 6 weeks and 7 weeks ] [ Designated as safety issue: No ]
- Microbiological response at EOIT, EOT and follow-up visit [ Time Frame: 7 days, 6 weeks and 7 weeks ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
- Safety and tolerability of anidulafungin and fluconazole including adverse events and laboratory tests. [ Time Frame: 7 weeks ] [ 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 |
| 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
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 | |
| Sir run run shaw hospital, Affiliated with school of medicine, Zhejiang University | |
| Hangzhou, Zhejiang, China, 310016 | |
| The First Affiliated Hospital of Medical School of Zhejiang University/Department of Hematology | |
| Hangzhou, Zhejiang, China, 310003 | |
| 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:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01176058 History of Changes |
| Other Study ID Numbers: | A8851023 |
| Study First Received: | August 3, 2010 |
| Last Updated: | January 12, 2012 |
| 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 Candidemia Candidiasis, Invasive Mycoses Fungemia Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
Fluconazole Anidulafungin Echinocandins Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013