Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections
NCT ID: NCT00424190
Last Updated: 2017-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
698 participants
INTERVENTIONAL
2007-02-28
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ceftaroline for Injection
Ceftaroline
600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
IV Vancomycin and IV Aztreonam
IV Vancomycin plus IV Aztreonam
vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days.
Interventions
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IV Vancomycin plus IV Aztreonam
vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days.
Ceftaroline
600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam.
18 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Cerexa, Inc
Principal Investigators
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Ralph Corey, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Investigational Site
Dothan, Alabama, United States
Investigational Site
Long Beach, California, United States
Investigational Site
Los Angeles, California, United States
Investigational Site
Sacramento, California, United States
Investigational Site
Sacramento, California, United States
Investigational Site
San Diego, California, United States
Investigational Site
San Francisco, California, United States
Investigational Site
Torrance, California, United States
Investigational Site
Savannah, Georgia, United States
Investigational Site
Naperville, Illinois, United States
Investigational Site
Indianapolis, Indiana, United States
Investigational Site
Shreveport, Louisiana, United States
Investigational Site
Columbus, Ohio, United States
Investigational Site
Landsdale, Pennsylvania, United States
Investigational Site
Tacoma, Washington, United States
Investigational Site
Buenos Aires, , Argentina
Investigational Site
Buenos Aires, , Argentina
Investigational Site
Buenos Aires, , Argentina
Invetigational Site
Buenos Aires, , Argentina
Investigational Site
Córdoba, , Argentina
Invetigational Site
Córdoba, , Argentina
Investigational Site
Entre Ríos, , Argentina
Investigational Site
Santa Fe, , Argentina
Investigational Site
Curiuba-Parans, , Brazil
Investigational Site
São Paulo, , Brazil
Investigational Site
Santiago, , Chile
Investigational Site
Viña del Mar, , Chile
Investigational Site
Berlin, , Germany
Investigational Site
Bochum, , Germany
Investigational Site
Hanau, , Germany
Investigational Site
Plauen, , Germany
Investigational Site
Quedlinburg, , Germany
Investigational Site
Chihuahua City, , Mexico
Invetigational Site
Lima, , Peru
Investigational Site
Bytom, , Poland
Investigational Site
Krakow, , Poland
Investigational Site
Lublin, , Poland
Investigational Site
Sosnowiec, , Poland
Investigational Site
Todz, , Poland
Investigational Site
Bucharest, , Romania
Investigational Site
Bucharest, , Romania
Investigational Site
Timișoara, , Romania
Investigational Site
Moscow, , Russia
Investigational Site
Moscow, , Russia
Investigational Site
Moscow, , Russia
Investigational Site
Saint Petersburg, , Russia
Investigational Site
Saint Petersburg, , Russia
Investigational Site
Saint Petersburg, , Russia
Investigational Site
Smolensk, , Russia
Investigational Site
Dnipropetrovsk, , Ukraine
Investigational Site
Ivano-Frankivsk, , Ukraine
Investigational Site
Lviv, , Ukraine
Countries
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References
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Dryden M, Kantecki M, Yan JL, Stone GG, Leister-Tebbe H, Wilcox M. Treatment outcomes of secondary bacteraemia in patients treated with ceftaroline fosamil: pooled results from six phase III clinical trials. J Glob Antimicrob Resist. 2022 Mar;28:108-114. doi: 10.1016/j.jgar.2021.10.027. Epub 2021 Dec 16.
Wilcox M, Yan JL, Gonzalez PL, Dryden M, Stone GG, Kantecki M. Impact of Underlying Comorbidities on Outcomes of Patients Treated with Ceftaroline Fosamil for Complicated Skin and Soft Tissue Infections: Pooled Results from Three Phase III Randomized Clinical Trials. Infect Dis Ther. 2022 Feb;11(1):217-230. doi: 10.1007/s40121-021-00557-w. Epub 2021 Nov 6.
Corey GR, Wilcox MH, Gonzalez J, Jandourek A, Wilson DJ, Friedland HD, Das S, Iaconis J, Dryden M. Ceftaroline fosamil therapy in patients with acute bacterial skin and skin-structure infections with systemic inflammatory signs: A retrospective dose comparison across three pivotal trials. Int J Antimicrob Agents. 2019 Jun;53(6):830-837. doi: 10.1016/j.ijantimicag.2019.01.016. Epub 2019 Feb 1.
Cheng K, Pypstra R, Yan JL, Hammond J. Summary of the safety and tolerability of two treatment regimens of ceftaroline fosamil: 600 mg every 8 h versus 600 mg every 12 h. J Antimicrob Chemother. 2019 Apr 1;74(4):1086-1091. doi: 10.1093/jac/dky519.
Corrado ML. Integrated safety summary of CANVAS 1 and 2 trials: Phase III, randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother. 2010 Nov;65 Suppl 4:iv67-iv71. doi: 10.1093/jac/dkq256.
Corey GR, Wilcox MH, Talbot GH, Thye D, Friedland D, Baculik T; CANVAS 1 investigators. CANVAS 1: the first Phase III, randomized, double-blind study evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother. 2010 Nov;65 Suppl 4:iv41-51. doi: 10.1093/jac/dkq254.
Corey GR, Wilcox M, Talbot GH, Friedland HD, Baculik T, Witherell GW, Critchley I, Das AF, Thye D. Integrated analysis of CANVAS 1 and 2: phase 3, multicenter, randomized, double-blind studies to evaluate the safety and efficacy of ceftaroline versus vancomycin plus aztreonam in complicated skin and skin-structure infection. Clin Infect Dis. 2010 Sep 15;51(6):641-50. doi: 10.1086/655827.
Other Identifiers
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P903-06
Identifier Type: -
Identifier Source: org_study_id
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