Bacterial Pneumonia Clinical Trial
— CAPOfficial 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
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.
Status | Completed |
Enrollment | 622 |
Est. completion date | June 2009 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Investigational Site | Autonoma | Buenos Aires |
Argentina | Investigational Site | Buenos Aires | |
Argentina | Investigational Site | Buenos Aires | |
Argentina | Investigational Site | Buenos Aires | |
Argentina | Investigational Site | Buenos Aires | |
Argentina | Investigational Site | Buenos Aires | |
Argentina | Investigational Site | Buenos Aires | |
Argentina | Investigational Site | Buenos Aires | |
Argentina | Investigational Site | Buenos Aires | |
Argentina | Invetigational Site | Buenos Aires | |
Argentina | Investigational Site | Cordoba | |
Argentina | Investigational Site | Cordoba | |
Argentina | Investigational Site | Cordoba | |
Argentina | INvestigational Site | Cordoba | |
Argentina | Investigational Site | Cordoba | |
Argentina | Investigational Site | Entre Rios | |
Argentina | Investigational Site | Granadero Baiggoria | |
Argentina | Investigational Site | Mar del Plata | Buenos Aires |
Argentina | Investigational Site | Merlo | Buenos Aires |
Argentina | Investigational Site | Parana | |
Argentina | Investigational Site | Santa Fe | |
Argentina | Investigational Site | Santa Fe | |
Austria | Investigational site | Grieskirchner | Wels |
Austria | Investigational Site | Steyr | |
Austria | Investigational Site | Wels | |
Austria | Investigational Site | Wien | |
Bulgaria | Investigational Site | Plovdiv | |
Bulgaria | Investigational Site | Rousse | |
Bulgaria | Investigational Site | Sofia | |
Bulgaria | Investigational Site | Sofia | |
Bulgaria | Investigational Site | Sofia | |
Bulgaria | Investigational Site | Sofia | |
Bulgaria | Investigational Drug | Varna | |
Chile | Investigational Site | San Ignacio | Valparaiso |
Chile | Investigational Site | Santiago | |
Chile | Investigational Site | Santiago | |
Chile | Investigational Site | Santiago | |
Chile | Investigational Site | Talcahuano | |
Chile | Investigational Site | Temuco | |
Chile | Inestigational Site | Valdivia | |
Chile | Investigational Site | Valdivia | |
Chile | Investigational Site | Valparaiso | |
Germany | Investigational Site | Aachen | |
Germany | Investigational Site | Aachen | |
Germany | Inestigational Site | Berlin | |
Germany | Investigational Site | Berlin | |
Germany | Investigational Site | Berlin | |
Germany | Investigational Site | Berlin | |
Germany | Investigational Site | Dachau | |
Germany | Investigational Site | Frankfurt | |
Germany | Investigational Site | Frankfurt am Main | |
Germany | Investigational Site | Greifswald | |
Germany | Investigational Site | Halle/Saale | |
Germany | Investigtional Site | Hannover | |
Germany | Investigational Site | Heidelberg | |
Germany | Investigational Site | Hofheim | |
Germany | Investigational Site | Immenhausen | |
Germany | Investigational Site | Lubeck | |
Germany | Investigational Site | Rotenburg | |
Germany | Investigational Site | Rotenburg (Wuemme) | |
Germany | Investigational Site | Wuppertal | |
Hungary | Investigational Site | Gyor | |
Hungary | Investigational Site | Nyiregyhaza | |
Hungary | Investigational Site | Nyiregyhaza | |
Hungary | Investigational Site | Seregelyesi | |
Hungary | Investigational Site | Sostoi | |
Hungary | Investigational Site | Szekesfehervar | |
Hungary | Investigational Site | Szent Instvan | |
Hungary | Investigational Site | Vasvari Pal | |
India | Investigational Site | Bangalore | |
India | Investigational Site | Gujarat | |
India | Investigational Site | Karnataka | |
India | Investigational Site | Karnataka | |
India | Investigational Site | Noida | |
India | Investigational Site | Pradesh | |
Latvia | Investigational Site | Daugavpils | |
Latvia | Investigational Site | Latvia | |
Latvia | Investigational Site | Liepaja | |
Latvia | Investigational Site | Riga | |
Mexico | Investigational Site | Chihuahua | |
Mexico | Investigational Site | Chihuahua | |
Mexico | Investigational Site | Jalisco | |
Mexico | Investigational Site | Jalisco | |
Mexico | Investigational Site | Jalisco | |
Mexico | Investigational Site | Lima | |
Mexico | Investigational Site | Sonora | |
Peru | Investigational Site | Lima | |
Peru | Investigational Site | Lima | |
Poland | Investigator Site | Bialystok | |
Poland | Investigational Site | Bystra | |
Poland | Investigational Site | Chrzanow | |
Poland | Investigational Site | Krakow | |
Poland | Investigational Site | Krakow | |
Poland | Investigational Site | Krakow | |
Poland | Investigtional Site | Krakow | |
Poland | Investigational Site | Lodz | |
Poland | Investigational Site | Lodz | |
Poland | Investigational Site | Lublin | |
Poland | Investigational Site | Poznan | |
Poland | Investigational Site | Poznan | |
Poland | Investigational Site | Skierniewice | |
Poland | Inestigational Site | Warszawa | |
Poland | Investigational Site | Warszawa | |
Poland | Investigational Site | Warszawa | |
Poland | Investigational Site | Warszawa | |
Poland | Investigational Site | Warszawa | |
Poland | Investigational Site | Wilkowice-Bystra | |
Poland | Investigational Site | Wroclaw | |
Poland | Investigational Site | Zabrze | |
Poland | Investigational Site | Zabrze | |
Romania | Investigational Site | Bucharest | |
Romania | Investigational Site | Bucharest | |
Romania | Investigational Site | Bucharest | |
Romania | Investigational Site | Bucharest | |
Romania | Investigational Site | Craiova | |
Russian Federation | Investigational Site | Moscow | |
Russian Federation | Investigational Site | Moscow | |
Russian Federation | Investigational Site | Moscow | |
Russian Federation | Investigational Site | Smolensk | |
Russian Federation | Investigational Site | St. Petersburg | |
Russian Federation | Investigational Site | St. Petersburg | |
Russian Federation | Investigational Site | St. Petersburg | |
Russian Federation | Investigational Site | St. Petersburg | |
Russian Federation | Investigational Site | St. Petersburg | |
Russian Federation | Investigational Site | ST. Petersburg | |
Russian Federation | Investigational Site | Yaroslavl | |
Ukraine | Investigational Site | Dnipropetrovsk | |
Ukraine | Investigational Site | Kharkiv | |
Ukraine | Investigational site | Kyiv | |
Ukraine | Investigational Site | Kyiv | |
Ukraine | Investigational site | Kyiv | |
Ukraine | Investigational Site | Vinnytsya | |
Ukraine | Investigational Site | Zaporizhya | |
Ukraine | Investigational Site | Zhytomyr | |
United States | Investigational Site | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories |
United States, Argentina, Austria, Bulgaria, Chile, Germany, Hungary, India, Latvia, Mexico, Peru, Poland, Romania, Russian Federation, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 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 | No |
Primary | 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 | No | |
Secondary | Clinical Response at End of Therapy (EOT) | Last day of study drug administration | No | |
Secondary | Microbiological Success Rate at TOC | 8-15 days after last dose of study drug | No | |
Secondary | Overall Clinical and Radiographic Success Rate at TOC | 8-15 days after last dose of study drug | No | |
Secondary | Clinical and Micriobiological Response by Pathogen at TOC | 8-15 days after last dose of study drug | No | |
Secondary | Clinical Relapse at Late Follow Up (LFU) Visit | 21-35 days after last dose of study drug | No | |
Secondary | Microbiological Reinfection/Recurrence at LFU | 21 to 35 days after last dose of study drug | No | |
Secondary | Evaluate Safety | first dose, throughout the treatment period, and up to the TOC visit | Yes |
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