Clinical trial NCT00509106: Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Pneumonia
Keywords: ceftaroline
Community-acquired pneumonia
CAP
Streptococcus pneumoniae
Haemophilus influenzae
Mycoplasma pneumoniae
Chlamydophila spp
Legionella ssp
multi-drug resistant Streptococcus pneumoniae (MDRSP)
antimicrobial resistance
pneumococci
beta-lactam
ceftaroline fosamil
ceftriaxone
antibiotic
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2007-07-31
Enrollment: 622
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Clinical trials is being held in different countries. 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: 8-15 days after last dose of study drug
measure: Clinical Cure Rate for Ceftaroline Compared With That for Ceftriaxone at TOC in the Clinically Evaluable (CE) Population
timeFrame: 8-15 days after last dose of study drug
Secondary outcomes:
measure: Clinical Response at End of Therapy (EOT)
timeFrame: Last day of study drug administration
measure: Microbiological Success Rate at TOC
timeFrame: 8-15 days after last dose of study drug
measure: Overall Clinical and Radiographic Success Rate at TOC
timeFrame: 8-15 days after last dose of study drug
measure: Clinical and Microbiological Response by Pathogen at TOC
timeFrame: 8-15 days after last dose of study drug
measure: Clinical Relapse at Late Follow Up (LFU) Visit
timeFrame: 21-35 days after last dose of study drug
measure: Microbiological Reinfection/Recurrence at LFU
timeFrame: 21 to 35 days after last dose of study drug
measure: Evaluate Safety
timeFrame: first dose, throughout the treatment period, and up to the TOC visit
Other outcomes:
Locations:
city: Durham
country: United States
facility: Investigational Site
state: North Carolina
city: Autonoma
country: Argentina
facility: Investigational Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Investigational Site
state: Buenos Aires
city: Merlo
country: Argentina
facility: Investigational Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Investigational Site
city: Buenos Aires
country: Argentina
facility: Investigational Site
city: Buenos Aires
country: Argentina
facility: Investigational Site
city: Buenos Aires
country: Argentina
facility: Investigational Site
city: Buenos Aires
country: Argentina
facility: Investigational Site
city: Buenos Aires
country: Argentina
facility: Investigational Site
city: Buenos Aires
country: Argentina
facility: Investigational Site
city: Buenos Aires
country: Argentina
facility: Investigational Site
city: Buenos Aires
country: Argentina
facility: Invetigational Site
city: Cordoba
country: Argentina
facility: Investigational Site
city: Cordoba
country: Argentina
facility: Investigational Site
city: Cordoba
country: Argentina
facility: Investigational Site
city: Cordoba
country: Argentina
facility: INvestigational Site
city: Cordoba
country: Argentina
facility: Investigational Site
city: Entre Rios
country: Argentina
facility: Investigational Site
city: Granadero Baiggoria
country: Argentina
facility: Investigational Site
city: Parana
country: Argentina
facility: Investigational Site
city: Santa Fe
country: Argentina
facility: Investigational Site
city: Santa Fe
country: Argentina
facility: Investigational Site
city: Grieskirchner
country: Austria
facility: Investigational site
state: Wels
city: Steyr
country: Austria
facility: Investigational Site
city: Wels
country: Austria
facility: Investigational Site
city: Wien
country: Austria
facility: Investigational Site
city: Plovdiv
country: Bulgaria
facility: Investigational Site
city: Rousse
country: Bulgaria
facility: Investigational Site
city: Sofia
country: Bulgaria
facility: Investigational Site
city: Sofia
country: Bulgaria
facility: Investigational Site
city: Sofia
country: Bulgaria
facility: Investigational Site
city: Sofia
country: Bulgaria
facility: Investigational Site
city: Varna
country: Bulgaria
facility: Investigational Drug
city: San Ignacio
country: Chile
facility: Investigational Site
state: Valparaiso
city: Santiago
country: Chile
facility: Investigational Site
city: Santiago
country: Chile
facility: Investigational Site
city: Santiago
country: Chile
facility: Investigational Site
city: Talcahuano
country: Chile
facility: Investigational Site
city: Temuco
country: Chile
facility: Investigational Site
city: Valdivia
country: Chile
facility: Inestigational Site
city: Valdivia
country: Chile
facility: Investigational Site
city: Valparaiso
country: Chile
facility: Investigational Site
city: Aachen
country: Germany
facility: Investigational Site
city: Aachen
country: Germany
facility: Investigational Site
city: Berlin
country: Germany
facility: Investigational Site
city: Berlin
country: Germany
facility: Inestigational Site
city: Berlin
country: Germany
facility: Investigational Site
city: Berlin
country: Germany
facility: Investigational Site
city: Dachau
country: Germany
facility: Investigational Site
city: Frankfurt am Main
country: Germany
facility: Investigational Site
city: Frankfurt
country: Germany
facility: Investigational Site
city: Greifswald
country: Germany
facility: Investigational Site
city: Halle/Saale
country: Germany
facility: Investigational Site
city: Hannover
country: Germany
facility: Investigtional Site
city: Heidelberg
country: Germany
facility: Investigational Site
city: Hofheim
country: Germany
facility: Investigational Site
city: Immenhausen
country: Germany
facility: Investigational Site
city: Lubeck
country: Germany
facility: Investigational Site
city: Rotenburg (Wuemme)
country: Germany
facility: Investigational Site
city: Rotenburg
country: Germany
facility: Investigational Site
city: Wuppertal
country: Germany
facility: Investigational Site
city: Gyor
country: Hungary
facility: Investigational Site
city: Nyiregyhaza
country: Hungary
facility: Investigational Site
city: Nyiregyhaza
country: Hungary
facility: Investigational Site
city: Seregelyesi
country: Hungary
facility: Investigational Site
city: Sostoi
country: Hungary
facility: Investigational Site
city: Szekesfehervar
country: Hungary
facility: Investigational Site
city: Szent Instvan
country: Hungary
facility: Investigational Site
city: Vasvari Pal
country: Hungary
facility: Investigational Site
city: Bangalore
country: India
facility: Investigational Site
city: Gujarat
country: India
facility: Investigational Site
city: Karnataka
country: India
facility: Investigational Site
city: Karnataka
country: India
facility: Investigational Site
city: Noida
country: India
facility: Investigational Site
city: Pradesh
country: India
facility: Investigational Site
city: Daugavpils
country: Latvia
facility: Investigational Site
city: Latvia
country: Latvia
facility: Investigational Site
city: Liepaja
country: Latvia
facility: Investigational Site
city: Riga
country: Latvia
facility: Investigational Site
city: Chihuahua
country: Mexico
facility: Investigational Site
city: Chihuahua
country: Mexico
facility: Investigational Site
city: Jalisco
country: Mexico
facility: Investigational Site
city: Jalisco
country: Mexico
facility: Investigational Site
city: Jalisco
country: Mexico
facility: Investigational Site
city: Lima
country: Mexico
facility: Investigational Site
city: Sonora
country: Mexico
facility: Investigational Site
city: Lima
country: Peru
facility: Investigational Site
city: Lima
country: Peru
facility: Investigational Site
city: Bialystok
country: Poland
facility: Investigator Site
city: Bystra
country: Poland
facility: Investigational Site
city: Chrzanow
country: Poland
facility: Investigational Site
city: Krakow
country: Poland
facility: Investigational Site
city: Krakow
country: Poland
facility: Investigational Site
city: Krakow
country: Poland
facility: Investigtional Site
city: Krakow
country: Poland
facility: Investigational Site
city: Lodz
country: Poland
facility: Investigational Site
city: Lodz
country: Poland
facility: Investigational Site
city: Lublin
country: Poland
facility: Investigational Site
city: Poznan
country: Poland
facility: Investigational Site
city: Poznan
country: Poland
facility: Investigational Site
city: Skierniewice
country: Poland
facility: Investigational Site
city: Warszawa
country: Poland
facility: Inestigational Site
city: Warszawa
country: Poland
facility: Investigational Site
city: Warszawa
country: Poland
facility: Investigational Site
city: Warszawa
country: Poland
facility: Investigational Site
city: Warszawa
country: Poland
facility: Investigational Site
city: Wilkowice-Bystra
country: Poland
facility: Investigational Site
city: Wroclaw
country: Poland
facility: Investigational Site
city: Zabrze
country: Poland
facility: Investigational Site
city: Zabrze
country: Poland
facility: Investigational Site
city: Bucharest
country: Romania
facility: Investigational Site
city: Bucharest
country: Romania
facility: Investigational Site
city: Bucharest
country: Romania
facility: Investigational Site
city: Bucharest
country: Romania
facility: Investigational Site
city: Craiova
country: Romania
facility: Investigational Site
city: Moscow
country: Russian Federation
facility: Investigational Site
city: Moscow
country: Russian Federation
facility: Investigational Site
city: Moscow
country: Russian Federation
facility: Investigational Site
city: Smolensk
country: Russian Federation
facility: Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Investigational Site
city: ST. Petersburg
country: Russian Federation
facility: Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Investigational Site
city: Kharkiv
country: Ukraine
facility: Investigational Site
city: Kyiv
country: Ukraine
facility: Investigational site
city: Kyiv
country: Ukraine
facility: Investigational Site
city: Kyiv
country: Ukraine
facility: Investigational site
city: Vinnytsya
country: Ukraine
facility: Investigational Site
city: Zaporizhya
country: Ukraine
facility: Investigational Site
city: Zhytomyr
country: Ukraine
facility: Investigational Site
Study officials:
affiliation: UMC Utrecht
name: IM Hoepelman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.