Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections
NCT ID: NCT01499277
Last Updated: 2017-09-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
802 participants
INTERVENTIONAL
2012-05-31
2015-01-31
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
Patients will receive 600 mg of ceftaroline fosamil administered as a 120-minute intravenous infusion very 8 hours. Each dose will be infused in a volume of 250 mL over 120-minutes followed by aztreonam placebo in a volume of 100 mL infused over 30 minutes every 8 hours. In addition vancomycin placebo will be given in a volume of 250 mL infused over 120 minutes every 12 hours. Doses will be adjusted according to the patient's renal function.
Ceftaroline fosamil
IV ceftaroline 600mg every 8 hours
Vancomycin plus aztreonam
Patients will receive combination of vancomycin plus aztreonam. Dose of vancomycin will be based on the patient's actual weight and will receive intravenous vancomycin every 12 hours with each dose infused over 120-minutes. Aztreonam dose will be 1 gram intravenously in a volume of 100 mL infused over 30 minutes every 8 hours. In addition, ceftaroline fosamil placebo will be given in a volume of 250 mL infused over 120 minutes every 8 hours. Doses adjusted according to patients renal function
Vancomycin
IV vancomycin 15mg/kg every 12 hours
Aztreonam
IV aztreonam 1 g every 8 hours
Interventions
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Ceftaroline fosamil
IV ceftaroline 600mg every 8 hours
Vancomycin
IV vancomycin 15mg/kg every 12 hours
Aztreonam
IV aztreonam 1 g every 8 hours
Eligibility Criteria
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Inclusion Criteria
* Complicated skin and skin structure infection (cSSTI)
* Infection of sufficient severity to warrant hospitalization
* Infection of sufficient severity such that it is expected to require at least 5 days of intravenous antibiotic therapy
Exclusion Criteria
* Uncomplicated skin and skin structure infections, skin infections suspected to be caused by viral or fungal pathogens
* Diabetic foot infections, decubitus ulcers, ulcers due to peripheral vascular disease
* Infection caused by human or animal bites, sternal wound infections, bone infection or arthritis due to an infection, critical limb ischemia of the affected limb
* Chronic liver disease or severe impaired renal function, severe low white blood cell count, burns on greater than 15% of total body surface area, necrotizing skin infection, amputation required of primary site of infection, sustained shock
18 Years
99 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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David Melnick, MSD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Chula Vista, California, United States
Research Site
Orlando, Florida, United States
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West Palm Beach, Florida, United States
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Carmel, Indiana, United States
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Hazard, Kentucky, United States
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Springfield, Massachusetts, United States
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Detroit, Michigan, United States
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Las Vegas, Nevada, United States
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Garden City, New York, United States
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Bellaire, Texas, United States
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Córdoba, , Argentina
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Santa Fe, , Argentina
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Parkville, , Australia
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Brussels, , Belgium
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Belo Horizonte, , Brazil
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Passo Fundo, , Brazil
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Salvador, , Brazil
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São José do Rio Preto, , Brazil
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Pleven, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Temuco, , Chile
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Viña del Mar, , Chile
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Beijing, , China
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Changchun, , China
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Changsha, , China
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Chengdu, , China
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Chongqing, , China
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Fuzhou, , China
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Guangzhou, , China
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Haikou, , China
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Nanning, , China
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Qingdao, , China
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Shanghai, , China
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Shenyang, , China
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Shijiazhuang, , China
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Wuhan, , China
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Xi'an, , China
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Slavonski Brod, , Croatia
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Zagreb, , Croatia
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Jihlava, , Czechia
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Pardubice, , Czechia
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Orléans, , France
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Dessau, , Germany
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Hanau, , Germany
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Heilbronn, , Germany
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Athens, , Greece
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Kowloon, , Hong Kong
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Pokfulam, , Hong Kong
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Haifa, , Israel
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Ramat Gan, , Israel
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Safed, , Israel
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Tel Aviv, , Israel
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Milan, , Italy
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Guadalajara, , Mexico
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Cusco, , Peru
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Lima, , Peru
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Manila, , Philippines
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Quezon City, , Philippines
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Lodz, , Poland
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Lublin, , Poland
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Bucharest, , Romania
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Moscow, , Russia
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Perm, , Russia
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Saint Petersburg, , Russia
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Smolensk, , Russia
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Vsevolozhsk, , Russia
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Yaroslavl, , Russia
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Benoni, , South Africa
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Cape Town, , South Africa
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Johannesburg, , South Africa
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Worcester, , South Africa
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Ansan, , South Korea
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Deagu, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Wŏnju, , South Korea
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Barcelona, , Spain
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Granada, , Spain
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Madrid, , Spain
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Terrassa, , Spain
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Kaohsiung City, , Taiwan
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Taipei, , Taiwan
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Yung Kang City, , Taiwan
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Ankara, , Turkey (Türkiye)
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Diyarbakır, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Cherkasy, , Ukraine
Research Site
Ivano-Frankivsk, , Ukraine
Research Site
Kharkiv, , Ukraine
Research Site
Odesa, , 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.
Sanchez-Garcia M, Hammond J, Yan JL, Kantecki M, Ansari W, Dryden M. Baseline Characteristics and Outcomes Among Patients with Complicated Skin and Soft Tissue Infections Admitted to the Intensive Care Unit: Analysis of the Phase 3 COVERS Randomized Trial of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam. Infect Dis Ther. 2020 Sep;9(3):609-623. doi: 10.1007/s40121-020-00297-3. Epub 2020 Jun 30.
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.
Das S, Li J, Iaconis J, Zhou D, Stone GG, Yan JL, Melnick D. Ceftaroline fosamil doses and breakpoints for Staphylococcus aureus in complicated skin and soft tissue infections. J Antimicrob Chemother. 2019 Feb 1;74(2):425-431. doi: 10.1093/jac/dky439.
Dryden M, Zhang Y, Wilson D, Iaconis JP, Gonzalez J. A Phase III, randomized, controlled, non-inferiority trial of ceftaroline fosamil 600 mg every 8 h versus vancomycin plus aztreonam in patients with complicated skin and soft tissue infection with systemic inflammatory response or underlying comorbidities. J Antimicrob Chemother. 2016 Dec;71(12):3575-3584. doi: 10.1093/jac/dkw333. Epub 2016 Sep 1.
Other Identifiers
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2011-004013-16
Identifier Type: -
Identifier Source: secondary_id
D3720C00001
Identifier Type: -
Identifier Source: org_study_id
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