Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections
NCT ID: NCT00423657
Last Updated: 2017-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
680 participants
INTERVENTIONAL
2007-03-31
2007-12-31
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 fosamil for Injection
Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
ceftaroline
600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
Placebo
Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
IV Vancomycin plus IV Aztreonam
Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
vancomycin plus 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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ceftaroline
600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
vancomycin plus 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.
Placebo
Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
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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Mark Wilcox, MD
Role: PRINCIPAL_INVESTIGATOR
Old Medical School
Locations
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Investigational Site
Buena Park, California, United States
Investigational Site
Hawaiian Gardens, California, United States
Investigational Site
Los Angeles, California, United States
Investigational Site
Pasadena, California, United States
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San Diego, California, United States
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San Jose, California, United States
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Atlantis, Florida, United States
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Columbus, Georgia, United States
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Marietta, Georgia, United States
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Springfield, Illinois, United States
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Baltimore, Maryland, United States
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Minneapolis, Minnesota, United States
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Butte, Montana, United States
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Somers Point, New Jersey, United States
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Toledo, Ohio, United States
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Tacoma, Washington, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, , Argentina
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Córdoba, , Argentina
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Santa Fe, , Argentina
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Braunau am Inn, , Austria
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Graz, , Austria
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Sankt Pölten, , Austria
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Sao Paula, , Brazil
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Temuco, , Chile
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Valdivia, , Chile
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Cottbus, , Germany
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Dortmund, , Germany
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Homburg/Saar, , Germany
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Mainz, , Germany
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Wiesbaden, , Germany
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Riga, , Latvia
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Guadalajara, Jalisco, Mexico
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Seattle Zapopan, Jalisco, Mexico
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Bielsko-Biala, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Moscow, , Russia
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Moscow, , Russia
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Moscow Region, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Lviv, , Ukraine
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Zaporizhya, , Ukraine
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London, , United Kingdom
Investigational Site
London, , United Kingdom
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.
Wilcox MH, Corey GR, Talbot GH, Thye D, Friedland D, Baculik T; CANVAS 2 investigators. CANVAS 2: the second 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:iv53-iv65. doi: 10.1093/jac/dkq255.
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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P903-07
Identifier Type: -
Identifier Source: org_study_id
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