Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia
NCT ID: NCT00509106
Last Updated: 2017-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
622 participants
INTERVENTIONAL
2007-07-31
2009-06-30
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 fosamil for injection
Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
Ceftaroline fosamil for Injection
2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours for 5 to 7 days
IV Ceftriaxone
Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
Ceftriaxone
1 g dose parenteral infused over 30 minutes, every 24 hours for 5 to 7 days
Placebo
Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind
Interventions
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Ceftaroline fosamil for Injection
2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours for 5 to 7 days
Ceftriaxone
1 g dose parenteral infused over 30 minutes, every 24 hours for 5 to 7 days
Placebo
Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* initial hospitalization or treatment in an emergency room or urgent care setting
* infection requiring initial treatment with IV antimicrobial
Exclusion Criteria
* Respiratory tract infections not due to community-acquired bacterial pathogens
* Infections resistant to ceftriaxone
* Any condition requiring concomitant systemic corticosteroids
* History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial
18 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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IM Hoepelman, MD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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Investigational Site
Durham, North Carolina, United States
Investigational Site
Autonoma, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Merlo, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
Invetigational Site
Buenos Aires, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
INvestigational Site
Córdoba, , Argentina
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Córdoba, , Argentina
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Entre Ríos, , Argentina
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Granadero Baiggoria, , Argentina
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Paraná, , Argentina
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Santa Fe, , Argentina
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Santa Fe, , Argentina
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Grieskirchner, Wels, Austria
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Steyr, , Austria
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Vienna, , Austria
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Wels, , Austria
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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San Ignacio, Región de Valparaíso, Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Talcahuano, , Chile
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Temuco, , Chile
Inestigational Site
Valdivia, , Chile
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Valdivia, , Chile
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Valparaíso, , Chile
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Aachen, , Germany
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Aachen, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Dachau, , Germany
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Frankfurt, , Germany
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Frankfurt am Main, , Germany
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Greifswald, , Germany
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Halle, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Hofheim, , Germany
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Immenhausen, , Germany
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Lübeck, , Germany
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Rotenburg (Wümme), , Germany
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Wuppertal, , Germany
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Győr, , Hungary
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Nyíregyháza, , Hungary
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Nyíregyháza, , Hungary
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Seregelyesi, , Hungary
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Sostoi, , Hungary
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Szent Instvan, , Hungary
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Székesfehérvár, , Hungary
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Vasvari Pal, , Hungary
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Bangalore, , India
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Gujarat, , India
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Karnataka, , India
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Karnataka, , India
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Noida, , India
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Pradesh, , India
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Daugavpils, , Latvia
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Latvia, , Latvia
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Liepāja, , Latvia
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Riga, , Latvia
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Chihuahua City, , Mexico
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Chihuahua City, , Mexico
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Jalisco, , Mexico
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Jalisco, , Mexico
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Jalisco, , Mexico
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Lima, , Mexico
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Sonora, , Mexico
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Lima, , Peru
Investigational Site
Lima, , Peru
Investigator Site
Bialystok, , Poland
Investigational Site
Bystra, , Poland
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Chrzanów, , Poland
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Krakow, , Poland
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Krakow, , Poland
Investigtional Site
Krakow, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Skierniewice, , Poland
Inestigational Site
Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wilkowice-Bystra, , Poland
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Wroclaw, , Poland
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Zabrze, , Poland
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Zabrze, , Poland
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Craiova, , 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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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Smolensk, , Russia
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Yaroslavl, , Russia
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Dnipropetrovsk, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Vinnytsia, , Ukraine
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Zaporizhya, , Ukraine
Investigational Site
Zhytomyr, , 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.
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.
Taboada M, Melnick D, Iaconis JP, Sun F, Zhong NS, File TM, Llorens L, Friedland HD, Wilson D. Ceftaroline fosamil versus ceftriaxone for the treatment of community-acquired pneumonia: individual patient data meta-analysis of randomized controlled trials. J Antimicrob Chemother. 2016 Apr;71(4):862-70. doi: 10.1093/jac/dkv415. Epub 2015 Dec 24.
Lodise TP, Anzueto AR, Weber DJ, Shorr AF, Yang M, Smith A, Zhao Q, Huang X, File TM. Assessment of time to clinical response, a proxy for discharge readiness, among hospitalized patients with community-acquired pneumonia who received either ceftaroline fosamil or ceftriaxone in two phase III FOCUS trials. Antimicrob Agents Chemother. 2015 Feb;59(2):1119-26. doi: 10.1128/AAC.03643-14. Epub 2014 Dec 8.
Shorr AF, Kollef M, Eckburg PB, Llorens L, Friedland HD. Assessment of ceftaroline fosamil in the treatment of community-acquired bacterial pneumonia due to Streptococcus pneumoniae: insights from two randomized trials. Diagn Microbiol Infect Dis. 2013 Mar;75(3):298-303. doi: 10.1016/j.diagmicrobio.2012.12.002. Epub 2013 Jan 26.
Rank DR, Friedland HD, Laudano JB. Integrated safety summary of FOCUS 1 and FOCUS 2 trials: Phase III randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with community-acquired pneumonia. J Antimicrob Chemother. 2011 Apr;66 Suppl 3:iii53-9. doi: 10.1093/jac/dkr099.
Low DE, File TM Jr, Eckburg PB, Talbot GH, David Friedland H, Lee J, Llorens L, Critchley IA, Thye DA; FOCUS 2 investigators. FOCUS 2: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia. J Antimicrob Chemother. 2011 Apr;66 Suppl 3:iii33-44. doi: 10.1093/jac/dkr097.
Other Identifiers
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P903-09
Identifier Type: -
Identifier Source: org_study_id
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