Clinical trial NCT00621504: Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects 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, With Adjunctive Clarithromycin, 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
IV (intravenous)
Streptococcus pneumoniae
Haemophilus influenzae
Mycoplasma pneumoniae
Chlamydophila spp
Legionella spp
Multi-drug resistant Streptococcus pneumoniae (MDRSP)
antimicrobial resistance
pneumococci
Ceftriaxone
bacteria
ß-lactam
beta-lactam
antibiotic
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 606
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 this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia

Detailed description: The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia. Clinical trials for this study is held in many countries

Eligibility criteria: Inclusion Criteria:

Subjects are required to meet the following inclusion criteria:

* Community-acquired pneumonia
* initial hospitalization, or treatment in an emergency room or urgent care setting
* infection would require initial treatment with IV antimicrobials.

Exclusion Criteria:

Subjects must NOT meet any of the following exclusion criteria:

* CAP suitable for outpatient therapy with an oral antimicrobial agent
* respiratory tract infections not due to community-acquired bacterial
* Non-infectious causes of pulmonary infiltrates
* Pleural empyema
* Infection with an atypical organism
* History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial
* History of any hypersensitivity or allergic reaction to clarithromycin or any macrolide/ ketolide

Primary outcomes:
measure: Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations
timeFrame: 8 to 15 days after last dose of study drug
measure: Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (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 Test of Cure (TOC)
timeFrame: 8-15 days after last dose of study drug
measure: Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC)
timeFrame: 8-15 days after last day 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)
timeFrame: 21-35 days after last dose of study drug
measure: Microbiological Re-infection/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: Los Angeles
country: United States
facility: Investigational site
state: California
city: Pasadena
country: United States
facility: Investigational Site
state: California
city: Sacramento
country: United States
facility: Investigational Site
state: California
city: San Diego
country: United States
facility: Investigational Site
state: California
city: Orlando
country: United States
facility: Investigational Site
state: Florida
city: Fort Gordon
country: United States
facility: Investigational Site
state: Georgia
city: Peoria
country: United States
facility: Investigational Site
state: Illinois
city: Baltimore
country: United States
facility: Investigational Site
state: Maryland
city: Minneapolis
country: United States
facility: Investigational site
state: Minnesota
city: Butte
country: United States
facility: Investigational Site
state: Montana
city: Akron
country: United States
facility: Investigational Site
state: Ohio
city: Houston
country: United States
facility: Investigational Site
state: Texas
city: Buenos Aires
country: Argentina
facility: Investigational Site
state: C.a.b.a.
city: San Miguel de Tucuman
country: Argentina
facility: Investigational Site
state: Tucuman
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: Vicente Lopez
country: Argentina
facility: Investigational Site
city: Vienna
country: Austria
facility: Investigational Site
city: Wien
country: Austria
facility: Investigational Site
city: Goiania
country: Brazil
facility: Investigational Site
state: G.o.
city: Porto Alegre
country: Brazil
facility: Investigational Site
state: RS
city: Porto Alegre
country: Brazil
facility: Investigational Site
state: RS
city: Sao Jose do Rio Preto
country: Brazil
facility: Investigational Site
state: SP
city: Belo Horizonte MG
country: Brazil
facility: Investigational Site 1
city: Belo Horizonte
country: Brazil
facility: Investigational Site 2
city: Campinas
country: Brazil
facility: Investigational Site
city: Curitiba-PR
country: Brazil
facility: Investigational Site
city: Juiz de Fora
country: Brazil
facility: Investigational Site
city: Porto Alegre
country: Brazil
facility: Investigational site
city: Sao Paolo
country: Brazil
facility: Investigational Site
city: Sao Paolo
country: Brazil
facility: Investigational Site
city: Burgas
country: Bulgaria
facility: Investigational Site
city: Sofia
country: Bulgaria
facility: Investigational Site
city: Varna
country: Bulgaria
facility: Investigational Site
city: Tallinn
country: Estonia
facility: Investigational Site
city: Tallinn
country: Estonia
facility: Investigational Site
city: Tartu
country: Estonia
facility: Investigational Site
city: Annecy
country: France
facility: Investigational Site
city: Argenteuil
country: France
facility: Investigational Site
city: Paris
country: France
facility: Investigational Site
city: Paris
country: France
facility: Investigational Site
city: Paris
country: France
facility: Investigational Site
city: Tbilisi
country: Georgia
facility: Investigational Site
city: Tbilisi
country: Georgia
facility: Investigational Site
city: Lindenberger
country: Germany
facility: Investigational Site
state: Berlin
city: Berlin
country: Germany
facility: Investigational Site
city: Bochum
country: Germany
facility: Investigational Site
city: Bochum
country: Germany
facility: Investigational Site
city: Erfurt
country: Germany
facility: Investigational Site
city: Heppenheim
country: Germany
facility: Investigational Site
city: Lich
country: Germany
facility: Investigational Site
city: Lubeck
country: Germany
facility: Investigational Site
city: Luedenscheid
country: Germany
facility: Investigational Site
city: Paderborn
country: Germany
facility: Investigational Site
city: Schkeuditz
country: Germany
facility: Investigational Site
city: Ulm
country: Germany
facility: Investigational Site
city: Wiesbaden
country: Germany
facility: Investigational Site
city: Tatabanya
country: Hungary
facility: Investigational Site
state: Szanatorium
city: Budapest
country: Hungary
facility: Investigational Site
city: Matrahaza
country: Hungary
facility: Investigational Site
city: Miskolc
country: Hungary
facility: Investigational Site
city: Pecs
country: Hungary
facility: Investigational Site
city: Sopron
country: Hungary
facility: Investigational Site
city: Tatabanya
country: Hungary
facility: Investigational Site
city: Torokbalint
country: Hungary
facility: Investigational Site
city: Vellore
country: India
facility: Investigational Site
state: Tamilnadu
city: Kaunas
country: Lithuania
facility: Investigational Site
city: Kaunas
country: Lithuania
facility: Investigational Site
city: Klaipeda
country: Lithuania
facility: Investigational Site
city: Klaipeda
country: Lithuania
facility: Investigational Site
city: Siauliai
country: Lithuania
facility: Investigational Site
city: Vilnius
country: Lithuania
facility: Investigational Site
city: Johor Bahru
country: Malaysia
facility: Investigational Site
state: Johor
city: Cheras
country: Malaysia
facility: Inestigational Site
state: Kuala Lumpur
city: Georgetown
country: Malaysia
facility: Investigational Site
state: Penang
city: Kedah
country: Malaysia
facility: Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Investigational Site
city: Bedzin
country: Poland
facility: Investigational Site
city: Brzesku
country: Poland
facility: Investigational Site
city: Bytom
country: Poland
facility: Investigational Site
city: Chodziez
country: Poland
facility: Investigational Site
city: Czestochowa
country: Poland
facility: Investigational Site
city: Katowice-Ochojec
country: Poland
facility: Investigational Site
city: Krakow
country: Poland
facility: Investigational Site
city: Lublin
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: Tychy
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: Warszawa
country: Poland
facility: Investigational Site
city: Wroclaw
country: Poland
facility: Investigational Site
city: Bucharest
country: Romania
facility: Inestigational Site
city: Bucharest
country: Romania
facility: Investigational Site
city: Cluj Napoca
country: Romania
facility: Investigational Site
city: Constanta
country: Romania
facility: Investigational Site
city: Oradea
country: Romania
facility: Investigational Site
city: St. Brasov
country: Romania
facility: Investigational Site
city: Targu Mures
country: Romania
facility: Investigational Site
city: Timisoara
country: Romania
facility: Investigational Site
city: Petrozavodsk
country: Russian Federation
facility: Investigational Site
state: Republic of Karelia
city: Arkhangelsk
country: Russian Federation
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: Rostov-on-Don
country: Russian Federation
facility: Investigational Site
city: Saratov
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: Tatarstan
country: Russian Federation
facility: Investigational Site
city: Yekaterinburg
country: Russian Federation
facility: Investigational Site
city: Yekaterinburg
country: Russian Federation
facility: Investigational Site
city: Belgrade
country: Serbia
facility: Investigational Site
city: Knez Selo
country: Serbia
facility: Investigational Site
city: Kragujevac
country: Serbia
facility: Investigational Site
city: Bratislava
country: Slovakia
facility: Investigational Site
city: Nitra-Zobor
country: Slovakia
facility: Slovakia
city: Bellville
country: South Africa
facility: Investigational Site
state: Capetown
city: Benomi
country: South Africa
facility: Investigational Site
city: Cape Town
country: South Africa
facility: Investigational Site
city: Cape Town
country: South Africa
facility: Investigational Site
city: Krugersdorp
country: South Africa
facility: Investigational Site
city: Port Elizabeth
country: South Africa
facility: Investigational Site
city: Pretoria
country: South Africa
facility: Investigational Site
city: Pretoria
country: South Africa
facility: Investigational Site
city: Pretoria
country: South Africa
facility: Investigational Site
city: Pretoria
country: South Africa
facility: Investigational Site
city: Somerset West
country: South Africa
facility: Investigational Site
city: Worcester
country: South Africa
facility: Investigational Site
city: Barcelona
country: Spain
facility: Investigational Site
city: Barcelona
country: Spain
facility: Investigational Site
city: Elche
country: Spain
facility: Investigational Site
city: Leon
country: Spain
facility: Investigational Site
city: Madrid
country: Spain
facility: Investigational Site
city: Valencia
country: Spain
facility: Investigational Site
city: Vizcaya
country: Spain
facility: Investigational Site
city: Biel
country: Switzerland
facility: Investigational Site
city: Geneve
country: Switzerland
facility: Investigational Site
city: La Chaux-de-Fonds
country: Switzerland
facility: Investigational Site
city: Lugano
country: Switzerland
facility: Investigational Site
city: Bangkok
country: Thailand
facility: Investigational Site
city: Bangkok
country: Thailand
facility: Investigational Site
city: Bangkok
country: Thailand
facility: InvestigationalSite
city: Bangkok
country: Thailand
facility: Investigational Site
city: Chiang Mai
country: Thailand
facility: Investigational Site
city: Khonkaen
country: Thailand
facility: Investigational Site
city: Nonthaburi
country: Thailand
facility: Investigational Site
city: Aviv
country: Ukraine
facility: Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Investigational Site
city: Donetsk
country: Ukraine
facility: Investigational Site
city: Ivano-Frankivsk
country: Ukraine
facility: Investigational Site
city: Kharkiv
country: Ukraine
facility: Investigational Site
city: Kharkiv
country: Ukraine
facility: Investigational Site
city: Kyiv
country: Ukraine
facility: Inestigational Site
city: Kyiv
country: Ukraine
facility: Investigational Site
city: Lugansk
country: Ukraine
facility: Investigational Site
city: Odesa
country: Ukraine
facility: Investigational Site
city: Poltava
country: Ukraine
facility: Investigational Site
city: Uzhorod
country: Ukraine
facility: Investigational Site
Study officials:
affiliation: Summa Health System
name: Thomas M File, MD, MS
role: STUDY_DIRECTOR
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: File TM Jr, Low DE, Eckburg PB, Talbot GH, Friedland HD, Lee J, Llorens L, Critchley IA, Thye DA; FOCUS 1 investigators. FOCUS 1: 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:iii19-32. doi: 10.1093/jac/dkr096.
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.