Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects 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, With Adjunctive Clarithromycin, in the Treatment of Adult Subjects With Community-Acquired Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621504
• Other study ID #: P903-08
• Status: Completed
• Phase: Phase 3
• First received: February 11, 2008
• Last updated: September 20, 2011
• Start date: January 2008
• Est. completion date: June 2009

Study information

• Verified date: September 2011
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardHong Kong: Department of HealthHong Kong: Ethics CommitteeHong Kong: Joint CUHK-NTEC Clinical Research Ethics CommitteeMalaysia: Ministry of HealthThailand: Ethical CommitteeThailand: Food and Drug AdministrationThailand: Khon Kaen University Ethics Committee for Human ResearchThailand: Ministry of Public HealthArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaArgentina: Human Research Bioethics CommitteeBrazil: Ministry of HealthBrazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance AgencyRussia: Ethics CommitteeRussia: Ministry of Health of the Russian FederationRussia: Pharmacological Committee, Ministry of HealthUkraine: Ministry of HealthUkraine: State Pharmacological Center - Ministry of HealthLithuania: Bioethics CommitteeLithuania: State Medicine Control Agency - Ministry of HealthBulgaria: Bulgarian Drug AgencyBulgaria: Ministry of HealthRomania: Ministry of Public HealthRomania: National Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 606
• Est. completion date: June 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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
• 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.

Locations

Country	Name	City	State
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	C.a.b.a.
Argentina	Investigational Site	San Miguel de Tucuman	Tucuman
Argentina	Investigational Site	Vicente Lopez
Austria	Investigational Site	Vienna
Austria	Investigational Site	Wien
Brazil	Investigational Site 2	Belo Horizonte
Brazil	Investigational Site 1	Belo Horizonte MG
Brazil	Investigational Site	Campinas
Brazil	Investigational Site	Curitiba-PR
Brazil	Investigational Site	Goiania	G.o.
Brazil	Investigational Site	Juiz de Fora
Brazil	Investigational site	Porto Alegre
Brazil	Investigational Site	Porto Alegre	RS
Brazil	Investigational Site	Porto Alegre	RS
Brazil	Investigational Site	Sao Jose do Rio Preto	SP
Brazil	Investigational Site	Sao Paolo
Brazil	Investigational Site	Sao Paolo
Bulgaria	Investigational Site	Burgas
Bulgaria	Investigational Site	Sofia
Bulgaria	Investigational Site	Varna
Estonia	Investigational Site	Tallinn
Estonia	Investigational Site	Tallinn
Estonia	Investigational Site	Tartu
France	Investigational Site	Annecy
France	Investigational Site	Argenteuil
France	Investigational Site	Paris
France	Investigational Site	Paris
France	Investigational Site	Paris
Georgia	Investigational Site	Tbilisi
Georgia	Investigational Site	Tbilisi
Germany	Investigational Site	Berlin
Germany	Investigational Site	Bochum
Germany	Investigational Site	Bochum
Germany	Investigational Site	Erfurt
Germany	Investigational Site	Heppenheim
Germany	Investigational Site	Lich
Germany	Investigational Site	Lindenberger	Berlin
Germany	Investigational Site	Lubeck
Germany	Investigational Site	Luedenscheid
Germany	Investigational Site	Paderborn
Germany	Investigational Site	Schkeuditz
Germany	Investigational Site	Ulm
Germany	Investigational Site	Wiesbaden
Hungary	Investigational Site	Budapest
Hungary	Investigational Site	Matrahaza
Hungary	Investigational Site	Miskolc
Hungary	Investigational Site	Pecs
Hungary	Investigational Site	Sopron
Hungary	Investigational Site	Tatabanya
Hungary	Investigational Site	Tatabanya	Szanatorium
Hungary	Investigational Site	Torokbalint
India	Investigational Site	Vellore	Tamilnadu
Lithuania	Investigational Site	Kaunas
Lithuania	Investigational Site	Kaunas
Lithuania	Investigational Site	Klaipeda
Lithuania	Investigational Site	Klaipeda
Lithuania	Investigational Site	Siauliai
Lithuania	Investigational Site	Vilnius
Malaysia	Inestigational Site	Cheras	Kuala Lumpur
Malaysia	Investigational Site	Georgetown	Penang
Malaysia	Investigational Site	Johor Bahru	Johor
Malaysia	Investigational Site	Kedah
Malaysia	Investigational Site	Kuala Lumpur
Poland	Investigational Site	Bedzin
Poland	Investigational Site	Brzesku
Poland	Investigational Site	Bytom
Poland	Investigational Site	Chodziez
Poland	Investigational Site	Czestochowa
Poland	Investigational Site	Katowice-Ochojec
Poland	Investigational Site	Krakow
Poland	Investigational Site	Lublin
Poland	Investigational Site	Lublin
Poland	Investigational Site	Poznan
Poland	Investigational Site	Poznan
Poland	Investigational Site	Tychy
Poland	Investigational Site	Warszawa
Poland	Investigational Site	Warszawa
Poland	Investigational Site	Warszawa
Poland	Investigational Site	Warszawa
Poland	Investigational Site	Wroclaw
Romania	Inestigational Site	Bucharest
Romania	Investigational Site	Bucharest
Romania	Investigational Site	Cluj Napoca
Romania	Investigational Site	Constanta
Romania	Investigational Site	Oradea
Romania	Investigational Site	St. Brasov
Romania	Investigational Site	Targu Mures
Romania	Investigational Site	Timisoara
Russian Federation	Investigational Site	Arkhangelsk
Russian Federation	Investigational Site	Moscow
Russian Federation	Investigational Site	Moscow
Russian Federation	Investigational Site	Moscow
Russian Federation	Investigational Site	Petrozavodsk	Republic of Karelia
Russian Federation	Investigational Site	Rostov-on-Don
Russian Federation	Investigational Site	Saratov
Russian Federation	Investigational Site	St Petersburg
Russian Federation	Investigational Site	St. Petersburg
Russian Federation	Investigational Site	St. Petersburg
Russian Federation	Investigational Site	Tatarstan
Russian Federation	Investigational Site	Yekaterinburg
Russian Federation	Investigational Site	Yekaterinburg
Serbia	Investigational Site	Belgrade
Serbia	Investigational Site	Knez Selo
Serbia	Investigational Site	Kragujevac
Slovakia	Investigational Site	Bratislava
Slovakia	Slovakia	Nitra-Zobor
South Africa	Investigational Site	Bellville	Capetown
South Africa	Investigational Site	Benomi
South Africa	Investigational Site	Cape Town
South Africa	Investigational Site	Cape Town
South Africa	Investigational Site	Krugersdorp
South Africa	Investigational Site	Port Elizabeth
South Africa	Investigational Site	Pretoria
South Africa	Investigational Site	Pretoria
South Africa	Investigational Site	Pretoria
South Africa	Investigational Site	Pretoria
South Africa	Investigational Site	Somerset West
South Africa	Investigational Site	Worcester
Spain	Investigational Site	Barcelona
Spain	Investigational Site	Barcelona
Spain	Investigational Site	Elche
Spain	Investigational Site	Leon
Spain	Investigational Site	Madrid
Spain	Investigational Site	Valencia
Spain	Investigational Site	Vizcaya
Switzerland	Investigational Site	Biel
Switzerland	Investigational Site	Geneve
Switzerland	Investigational Site	La Chaux-de-Fonds
Switzerland	Investigational Site	Lugano
Thailand	Investigational Site	Bangkok
Thailand	Investigational Site	Bangkok
Thailand	Investigational Site	Bangkok
Thailand	InvestigationalSite	Bangkok
Thailand	Investigational Site	Chiang Mai
Thailand	Investigational Site	Khonkaen
Thailand	Investigational Site	Nonthaburi
Ukraine	Investigational Site	Aviv
Ukraine	Investigational Site	Dnipropetrovsk
Ukraine	Investigational Site	Dnipropetrovsk
Ukraine	Investigational Site	Donetsk
Ukraine	Investigational Site	Ivano-Frankivsk
Ukraine	Investigational Site	Kharkiv
Ukraine	Investigational Site	Kharkiv
Ukraine	Inestigational Site	Kyiv
Ukraine	Investigational Site	Kyiv
Ukraine	Investigational Site	Lugansk
Ukraine	Investigational Site	Odesa
Ukraine	Investigational Site	Poltava
Ukraine	Investigational Site	Uzhorod
United States	Investigational Site	Akron	Ohio
United States	Investigational Site	Baltimore	Maryland
United States	Investigational Site	Butte	Montana
United States	Investigational Site	Fort Gordon	Georgia
United States	Investigational Site	Houston	Texas
United States	Investigational site	Los Angeles	California
United States	Investigational site	Minneapolis	Minnesota
United States	Investigational Site	Orlando	Florida
United States	Investigational Site	Pasadena	California
United States	Investigational Site	Peoria	Illinois
United States	Investigational Site	Sacramento	California
United States	Investigational Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Brazil,  Bulgaria,  Estonia,  France,  Georgia,  Germany,  Hungary,  India,  Lithuania,  Malaysia,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Switzerland,  Thailand,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations	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 to 15 days after last dose of study drug	No
Primary	Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (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 Test of Cure (TOC)		8-15 days after last dose of study drug	No
Secondary	Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC)		8-15 days after last day of study drug	No
Secondary	Clinical and Microbiological Response by Pathogen at TOC		8-15 days after last dose of study drug	No
Secondary	Clinical Relapse at Late Follow Up (LFU)		21-35 days after last dose of study drug	No
Secondary	Microbiological Re-infection/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