Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia
CAP
A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Ceftriaxone in the Treatment of Adult Subjects With Community-Acquired Pneumonia
1 other identifier
interventional
622
15 countries
134
Brief Summary
The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2007
134 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 27, 2007
CompletedFirst Posted
Study publicly available on registry
July 31, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
November 8, 2010
CompletedMarch 14, 2017
February 1, 2017
1.1 years
July 27, 2007
October 12, 2010
February 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population
Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary Failure: Any of the following: * Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy * Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia * Death wherein pneumonia (ie,CABP) was considered causative Indeterminate: Inability to determine an outcome
8-15 days after last dose of study drug
Clinical Cure Rate for Ceftaroline Compared With That for Ceftriaxone at TOC in the Clinically Evaluable (CE) Population
8-15 days after last dose of study drug
Secondary Outcomes (7)
Clinical Response at End of Therapy (EOT)
Last day of study drug administration
Microbiological Success Rate at TOC
8-15 days after last dose of study drug
Overall Clinical and Radiographic Success Rate at TOC
8-15 days after last dose of study drug
Clinical and Microbiological Response by Pathogen at TOC
8-15 days after last dose of study drug
Clinical Relapse at Late Follow Up (LFU) Visit
21-35 days after last dose of study drug
- +2 more secondary outcomes
Study Arms (2)
Ceftaroline fosamil for injection
EXPERIMENTALCeftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
IV Ceftriaxone
ACTIVE COMPARATORCeftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
Interventions
2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours for 5 to 7 days
1 g dose parenteral infused over 30 minutes, every 24 hours for 5 to 7 days
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
Eligibility Criteria
You may qualify if:
- Subjects with community-acquired pneumonia requiring:
- initial hospitalization or treatment in an emergency room or urgent care setting
- infection requiring initial treatment with IV antimicrobial
You may not qualify if:
- Community-acquired pneumonia suitable for outpatient therapy with an oral antimicrobial agent
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (134)
Investigational Site
Durham, North Carolina, 27710, United States
Investigational Site
Autonoma, Buenos Aires, B1722FJN, Argentina
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Mar del Plata, Buenos Aires, 7600, Argentina
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Merlo, Buenos Aires, B1722FJN, Argentina
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Córdoba, Córdoba Province, X5000HGX, Argentina
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Buenos Aires, 174, Argentina
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Buenos Aires, B1602DOH, Argentina
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Buenos Aires, B1657BHD, Argentina
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Buenos Aires, B1870CID, Argentina
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Buenos Aires, B1902AVG, Argentina
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Buenos Aires, B8000AAT, Argentina
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Buenos Aires, C1039AAO, Argentina
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Buenos Aires, C1180AAX, Argentina
Invetigational Site
Buenos Aires, Argentina
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Córdoba, 520, Argentina
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Córdoba, X5000JQB, Argentina
INvestigational Site
Córdoba, X5000JRD, Argentina
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Córdoba, X5004CDT, Argentina
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Entre Ríos, E3100BBJ, Argentina
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Granadero Baiggoria, S152EDD, Argentina
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Paraná, E3100BBJ, Argentina
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Santa Fe, S2152EDD, Argentina
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Santa Fe, S3000EOY, Argentina
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Grieskirchner, Wels, 4600, Austria
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Steyr, 4400, Austria
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Vienna, 1141, Austria
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Wels, 42, Austria
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Plovdiv, 4002, Bulgaria
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Rousse, 7000, Bulgaria
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Sofia, 1233, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1606, Bulgaria
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Sofia, 1784, Bulgaria
Investigational Drug
Varna, 9010, Bulgaria
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San Ignacio, Región de Valparaíso, 725, Chile
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Santiago, 3 Piso, Chile
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Santiago, 4 Piso, Chile
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Santiago, Chile
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Talcahuano, Chile
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Temuco, Chile
Inestigational Site
Valdivia, Of.5, Chile
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Valdivia, Chile
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Valparaíso, Chile
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Aachen, 52057, Germany
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Aachen, D-52057, Germany
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Berlin, 12559, Germany
Inestigational Site
Berlin, 14165, Germany
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Berlin, 14165, Germany
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Berlin, D-12351, Germany
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Dachau, 85221, Germany
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Frankfurt, 60487, Germany
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Frankfurt am Main, 60487, Germany
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Greifswald, 17475, Germany
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Halle, 06120, Germany
Investigtional Site
Hanover, 30625, Germany
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Heidelberg, 69120, Germany
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Hofheim, 65719, Germany
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Immenhausen, 34376, Germany
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Lübeck, 23538, Germany
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Rotenburg (Wümme), 27356, Germany
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Wuppertal, 42283, Germany
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Győr, 9023, Hungary
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Nyíregyháza, 4400, Hungary
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Nyíregyháza, 4412, Hungary
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Seregelyesi, ut3, Hungary
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Sostoi, ut.62, Hungary
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Szent Instvan, u.68, Hungary
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Székesfehérvár, 8000, Hungary
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Vasvari Pal, u.2, Hungary
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Bangalore, 560034, India
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Gujarat, 380054, India
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Karnataka, 560054, India
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Karnataka, 575001, India
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Noida, 201301, India
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Pradesh, India
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Daugavpils, LV-5417, Latvia
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Latvia, LV-1002, Latvia
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Liepāja, LV-5417, Latvia
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Riga, LV-1001, Latvia
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Chihuahua City, 31238, Mexico
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Chihuahua City, CP44280, Mexico
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Jalisco, 44280, Mexico
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Jalisco, 45170, Mexico
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Jalisco, CP44280, Mexico
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Lima, Mexico
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Sonora, 83000, Mexico
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Lima, 1, Peru
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Lima, 31, Peru
Investigator Site
Bialystok, 15-540, Poland
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Bystra, 43-360, Poland
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Chrzanów, 32-500, Poland
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Krakow, 31-066, Poland
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Krakow, 31-202, Poland
Investigtional Site
Krakow, 31-202, Poland
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Krakow, 31-531, Poland
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Lodz, 90-153, Poland
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Lodz, 91-520, Poland
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Lublin, 20-954, Poland
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Poznan, 60-531, Poland
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Poznan, 60-569, Poland
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Skierniewice, 96-100, Poland
Inestigational Site
Warsaw, 00-909, Poland
Investigational Site
Warsaw, 00-909, Poland
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Warsaw, 01-138, Poland
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Warsaw, 02-097, Poland
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Warsaw, 04-073, Poland
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Wilkowice-Bystra, 43-365, Poland
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Wroclaw, 50-417, Poland
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Zabrze, 41-800, Poland
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Zabrze, 41-803, Poland
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Bucharest, 010825, Romania
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Bucharest, 030303, Romania
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Bucharest, 050098, Romania
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Bucharest, 21659, Romania
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Craiova, 200515, Romania
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Moscow, 109240, Russia
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Moscow, 111020, Russia
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Moscow, 115446, Russia
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Saint Petersburg, 191015, Russia
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Saint Petersburg, 191180, Russia
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Saint Petersburg, 194017, Russia
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Saint Petersburg, 194291, Russia
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Saint Petersburg, 194354, Russia
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Saint Petersburg, 197022, Russia
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Smolensk, 214019, Russia
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Yaroslavl, 150062, Russia
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Dnipropetrovsk, 49044, Ukraine
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Kharkiv, 61039, Ukraine
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Kyiv, 01133, Ukraine
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Kyiv, 03115, Ukraine
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Kyiv, 03680, Ukraine
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Vinnytsia, 21000, Ukraine
Investigational Site
Zaporizhya, 69035, Ukraine
Investigational Site
Zhytomyr, 10002, Ukraine
Related Publications (7)
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.
PMID: 34922058DERIVEDCheng 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.
PMID: 30597021DERIVEDTaboada 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.
PMID: 26702925DERIVEDLodise 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.
PMID: 25487791DERIVEDShorr 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.
PMID: 23357290DERIVEDRank 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.
PMID: 21482570DERIVEDLow 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.
PMID: 21482568DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Clinical Sciences
- Organization
- Cerexa, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
IM Hoepelman, MD
UMC Utrecht
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2007
First Posted
July 31, 2007
Study Start
July 1, 2007
Primary Completion
August 1, 2008
Study Completion
June 1, 2009
Last Updated
March 14, 2017
Results First Posted
November 8, 2010
Record last verified: 2017-02