Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study
NCT ID: NCT00689338
Last Updated: 2011-05-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
216 participants
INTERVENTIONAL
2008-07-31
2010-05-31
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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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group
Option to treat with oral azole therapy following treatment with anidulafungin
Anidulafungin
Anidulafungin Intravenous Administration
Fluconazole
Oral Administration of Fluconazole
Voriconazole
Oral Administration of Voriconazole
Interventions
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Anidulafungin
Anidulafungin Intravenous Administration
Fluconazole
Oral Administration of Fluconazole
Voriconazole
Oral Administration of Voriconazole
Eligibility Criteria
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Inclusion Criteria
* Post-abdominal surgery.
* Elderly \> 65 years old.
* Renal insufficiency / failure / hemodialysis.
* Solid tumor.
* Solid-organ (liver, kidney, lung, heart) transplant recipients.
* Hepatic insufficiency.
* Neutropenic including hematology oncology patients.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Vienna, , Austria
Pfizer Investigational Site
Brussels, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Yvoir, , Belgium
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Hamilton, Ontario, Canada
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Hamilton, Ontario, Canada
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Québec, Quebec, Canada
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Brno, , Czechia
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Ostrava, , Czechia
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Prague, , Czechia
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Koebenhavn OE, , Denmark
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Odense C, , Denmark
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Amiens, France, France
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Bordeaux, France, France
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Clichy, France, France
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Lyon, France, France
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Marseille, France, France
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Montpellier, France, France
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Paris, France, France
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Villejuif, , France
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Berlin, , Germany
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Freiburg im Breisgau, , Germany
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Wuppertal, , Germany
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Kifissia, Athens, Greece
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Haidari, Attica, Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Pisa, , Italy
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Roma, , Italy
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Roma, , Italy
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Torino, , Italy
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Udine, , Italy
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Ede, , Netherlands
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Rotterdam, , Netherlands
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Krakow, , Poland
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Lodz, , Poland
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Coimbra, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Iași, Iaşi, Romania
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Bucharest, , Romania
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Görükle, Bursa, Turkey (Türkiye)
Pfizer Investigational Site
Ankara, , Turkey (Türkiye)
Pfizer Investigational Site
Trabzon, , Turkey (Türkiye)
Pfizer Investigational Site
Dnipropetrovsk, , Ukraine
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Donetsk, , Ukraine
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Leeds, West Yorkshire, United Kingdom
Pfizer Investigational Site
Liverpool, , United Kingdom
Pfizer Investigational Site
London, , United Kingdom
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.
Sganga G, Wang M, Capparella MR, Tawadrous M, Yan JL, Aram JA, Montravers P. Evaluation of anidulafungin in the treatment of intra-abdominal candidiasis: a pooled analysis of patient-level data from 5 prospective studies. Eur J Clin Microbiol Infect Dis. 2019 Oct;38(10):1849-1856. doi: 10.1007/s10096-019-03617-9. Epub 2019 Jul 6.
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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To obtain contact information for a study center near you, click here.
Other Identifiers
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A8851019
Identifier Type: -
Identifier Source: org_study_id