An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System
NCT ID: NCT00806351
Last Updated: 2012-12-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE3
21 participants
INTERVENTIONAL
2009-08-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Anidulafungin Arm
Subjects were randomized 2:1 (anidulafungin:caspofunin).
Active Anidulafungin
Subjects in this arm will receive active anidulafungin and placebo caspofungin
Caspofungin Arm
Subjects were randomized 2:1 (anidulafungin:caspofunin).
Active Caspofungin
Subjects in this arm will receive active caspofungin and placebo anidulafungin
Interventions
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Active Anidulafungin
Subjects in this arm will receive active anidulafungin and placebo caspofungin
Active Caspofungin
Subjects in this arm will receive active caspofungin and placebo anidulafungin
Eligibility Criteria
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Inclusion Criteria
* Confirmed Candida infection, defined as growth of Candida from a normally sterile site accompanied by signs and symptoms of infection.
* Male of female ≥16 years of age.
* Expected hospitalization for at least ten (10) days.
Exclusion Criteria
* Recent treatment with one of the study drugs over the last 30 days.
* Allergy to either study drug or to this class of drugs.
* Significant liver dysfunction.
* Suspected Candida osteomyelitis, endocarditis, meningitis or any other infections of the central nervous system.
16 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Sarajevo, , Bosnia and Herzegovina
Pfizer Investigational Site
Grenoble, , France
Pfizer Investigational Site
Strasbourg, , France
Pfizer Investigational Site
Bologna, , Italy
Pfizer Investigational Site
Roma, , Italy
Pfizer Investigational Site
Gdansk, , Poland
Pfizer Investigational Site
Warsaw, , Poland
Pfizer Investigational Site
Wroclaw, , Poland
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Košice, , Slovakia
Countries
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References
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De Rosa FG, Busca A, Capparella MR, Yan JL, Aram JA. Invasive Candidiasis in Patients with Solid Tumors Treated with Anidulafungin: A Post Hoc Analysis of Efficacy and Safety of Six Pooled Studies. Clin Drug Investig. 2021 Jun;41(6):539-548. doi: 10.1007/s40261-021-01024-7. Epub 2021 Apr 23.
Kontoyiannis DP, Bassetti M, Nucci M, Capparella MR, Yan JL, Aram J, Hogan PA. Anidulafungin for the treatment of candidaemia caused by Candida parapsilosis: Analysis of pooled data from six prospective clinical studies. Mycoses. 2017 Oct;60(10):663-667. doi: 10.1111/myc.12641. Epub 2017 Jun 9.
Kullberg BJ, Vasquez J, Mootsikapun P, Nucci M, Paiva JA, Garbino J, Yan JL, Aram J, Capparella MR, Conte U, Schlamm H, Swanson R, Herbrecht R. Efficacy of anidulafungin in 539 patients with invasive candidiasis: a patient-level pooled analysis of six clinical trials. J Antimicrob Chemother. 2017 Aug 1;72(8):2368-2377. doi: 10.1093/jac/dkx116.
Related Links
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Other Identifiers
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A8851021
Identifier Type: -
Identifier Source: org_study_id