Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia
NCT ID: NCT00621504
Last Updated: 2017-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
606 participants
INTERVENTIONAL
2008-01-31
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).
In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
Ceftaroline fosamil for Injection
2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours, for 5 to 7 days
Clarithromycin
In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
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).
In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
IV 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
Clarithromycin
In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
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
IV 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
Clarithromycin
In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
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 would require initial treatment with IV antimicrobials.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas M File, MD, MS
Role: STUDY_DIRECTOR
Summa Health System
Locations
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Investigational site
Los Angeles, California, United States
Investigational Site
Pasadena, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Orlando, Florida, United States
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Fort Gordon, Georgia, United States
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Peoria, Illinois, United States
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Baltimore, Maryland, United States
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Minneapolis, Minnesota, United States
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Butte, Montana, United States
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Akron, Ohio, United States
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Houston, Texas, United States
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Buenos Aires, C.a.b.a., Argentina
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San Miguel de Tucumán, Tucumán 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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Vicente López, , Argentina
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Vienna, , Austria
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Vienna, , Austria
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Goiânia, G.o., Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São José do Rio Preto, São Paulo, Brazil
Investigational Site 2
Belo Horizonte, , Brazil
Investigational Site 1
Belo Horizonte MG, , Brazil
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Campinas, , Brazil
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Curitiba-PR, , Brazil
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Juiz de Fora, , Brazil
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Porto Alegre, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Burgas, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Tallinn, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Annecy, , France
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Argenteuil, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Lindenberger, State of Berlin, Germany
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Berlin, , Germany
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Bochum, , Germany
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Bochum, , Germany
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Erfurt, , Germany
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Heppenheim an der Bergstrasse, , Germany
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Lich, , Germany
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Lübeck, , Germany
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Lüdenscheid, , Germany
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Paderborn, , Germany
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Schkeuditz, , Germany
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Ulm, , Germany
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Wiesbaden, , Germany
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Tatabánya, Szanatorium, Hungary
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Budapest, , Hungary
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Mátraháza, , Hungary
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Miskolc, , Hungary
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Pécs, , Hungary
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Sopron, , Hungary
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Tatabánya, , Hungary
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Törökbálint, , Hungary
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Vellore, Tamil Nadu, India
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Kaunas, , Lithuania
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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Klaipėda, , Lithuania
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Šiauliai, , Lithuania
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Vilnius, , Lithuania
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Johor Bahru, Johor, Malaysia
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Cheras, Kuala Lumpur, Malaysia
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George Town, Pulau Pinang, Malaysia
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Kedah, , Malaysia
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Kuala Lumpur, , Malaysia
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Będzin, , Poland
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Brzesku, , Poland
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Bytom, , Poland
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Chodzież, , Poland
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Częstochowa, , Poland
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Katowice-Ochojec, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Tychy, , 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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Wroclaw, , Poland
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Bucharest, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Constanța, , Romania
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Oradea, , Romania
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Saint Brasov, , Romania
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Târgu Mureş, , Romania
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Timișoara, , Romania
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Petrozavodsk, Republic of Karelia, Russia
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Arkhangelsk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Rostov-on-Don, , 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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Saratov, , Russia
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Tatarstan, , Russia
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Yekaterinburg, , Russia
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Yekaterinburg, , Russia
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Belgrade, , Serbia
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Knez-Selo, , Serbia
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Kragujevac, , Serbia
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Bratislava, , Slovakia
Slovakia
Nitra-Zobor, , Slovakia
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Bellville, Capetown, South Africa
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Benomi, , South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
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Krugersdorp, , South Africa
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Port Elizabeth, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
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Somerset West, , South Africa
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Worcester, , South Africa
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Barcelona, , Spain
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Barcelona, , Spain
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Elche, , Spain
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León, , Spain
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Madrid, , Spain
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Valencia, , Spain
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Vizcaya, , Spain
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Biel, , Switzerland
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Geneva, , Switzerland
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La Chaux-de-Fonds, , Switzerland
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Lugano, , Switzerland
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Khonkaen, , Thailand
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Nonthaburi, , Thailand
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Aviv, , Ukraine
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Dnipropetrovsk, , Ukraine
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Dnipropetrovsk, , Ukraine
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Donetsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
Inestigational Site
Kyiv, , Ukraine
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Kyiv, , Ukraine
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Luhansk, , Ukraine
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Odesa, , Ukraine
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Poltava, , Ukraine
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Uzhhorod, , 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.
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.
Other Identifiers
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P903-08
Identifier Type: -
Identifier Source: org_study_id
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