Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia

Bacterial Pneumonia Clinical Trial

— CAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00509106
• Other study ID #: P903-09
• Status: Completed
• Phase: Phase 3
• First received: July 27, 2007
• Last updated: November 9, 2010
• Start date: July 2007
• Est. completion date: June 2009

Study information

• Verified date: November 2010
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaArgentina: Human Research Bioethics CommitteeChile: Comisión Nacional de Investigación Científica y TecnológicaChile: Instituto de Salud Pública de ChilePeru: Ethics CommitteePeru: General Directorate of Pharmaceuticals, Devices, and DrugsPeru: Ministry of HealthMexico: Ethics CommitteeMexico: Ministry of HealthMexico: Federal Commission for Protection Against Health RisksGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPoland: Ministry of HealthAustria: Agency for Health and Food SafetyAustria: EthikkommissionHungary: National Institute of PharmacyUkraine: Ministry of HealthUkraine: State Pharmacological Center - Ministry of HealthRussia: Ethics CommitteeRussia: Ministry of Health of the Russian FederationRomania: National Medicines AgencyRomania: State Institute for Drug ControlBulgaria: Bulgarian Drug AgencyBulgaria: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Pneumonia
• Pneumonia
• Pneumonia, Bacterial

Intervention

Drug:
• Ceftaroline fosamil for Injection
2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours for 5 to 7 days
• Ceftriaxone
1 g dose parenteral infused over 30 minutes 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Bulgaria,  Chile,  Germany,  Hungary,  India,  Latvia,  Mexico,  Peru,  Poland,  Romania,  Russian Federation,  Ukraine, 

Outcome

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