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

PHASE3CompletedINTERVENTIONAL
Enrollment

622

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

August 31, 2008

Study Completion Date

June 30, 2009

Conditions
Bacterial Pneumonia
Interventions
DRUG

Ceftaroline fosamil for Injection

2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours for 5 to 7 days

DRUG

Ceftriaxone

1 g dose parenteral infused over 30 minutes, every 24 hours for 5 to 7 days

DRUG

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

Trial Locations (134)

1

Investigational Site, Lima

31

Investigational Site, Lima

42

Investigational Site, Wels

174

Investigational Site, Buenos Aires

520

Investigational Site, Córdoba

725

Investigational Site, San Ignacio

1141

Investigational Site, Vienna

1233

Investigational Site, Sofia

1431

Investigational Site, Sofia

1606

Investigational Site, Sofia

1784

Investigational Site, Sofia

4002

Investigational Site, Plovdiv

4400

Investigational Site, Steyr

Investigational Site, Nyíregyháza

4412

Investigational Site, Nyíregyháza

4600

Investigational site, Grieskirchner

7000

Investigational Site, Rousse

7600

Investigational Site, Mar del Plata

8000

Investigational Site, Székesfehérvár

9010

Investigational Drug, Varna

9023

Investigational Site, Győr

10002

Investigational Site, Zhytomyr

12559

Investigational Site, Berlin

14165

Inestigational Site, Berlin

Investigational Site, Berlin

17475

Investigational Site, Greifswald

21000

Investigational Site, Vinnytsia

21659

Investigational Site, Bucharest

23538

Investigational Site, Lübeck

27356

Investigational Site, Rotenburg (Wümme)

27710

Investigational Site, Durham

30625

Investigtional Site, Hanover

31238

Investigational Site, Chihuahua City

34376

Investigational Site, Immenhausen

42283

Investigational Site, Wuppertal

44280

Investigational Site, Jalisco

45170

Investigational Site, Jalisco

49044

Investigational Site, Dnipropetrovsk

52057

Investigational Site, Aachen

60487

Investigational Site, Frankfurt

Investigational Site, Frankfurt am Main

61039

Investigational Site, Kharkiv

65719

Investigational Site, Hofheim

69035

Investigational Site, Zaporizhya

69120

Investigational Site, Heidelberg

83000

Investigational Site, Sonora

85221

Investigational Site, Dachau

109240

Investigational Site, Moscow

111020

Investigational Site, Moscow

115446

Investigational Site, Moscow

150062

Investigational Site, Yaroslavl

191015

Investigational Site, Saint Petersburg

191180

Investigational Site, Saint Petersburg

194017

Investigational Site, Saint Petersburg

194291

Investigational Site, Saint Petersburg

194354

Investigational Site, Saint Petersburg

197022

Investigational Site, Saint Petersburg

200515

Investigational Site, Craiova

201301

Investigational Site, Noida

214019

Investigational Site, Smolensk

380054

Investigational Site, Gujarat

560034

Investigational Site, Bangalore

560054

Investigational Site, Karnataka

575001

Investigational Site, Karnataka

B1722FJN

Investigational Site, Autonoma

Investigational Site, Merlo

X5000HGX

Investigational Site, Córdoba

B1602DOH

Investigational Site, Buenos Aires

B1657BHD

Investigational Site, Buenos Aires

B1870CID

Investigational Site, Buenos Aires

B1902AVG

Investigational Site, Buenos Aires

B8000AAT

Investigational Site, Buenos Aires

C1039AAO

Investigational Site, Buenos Aires

C1180AAX

Investigational Site, Buenos Aires

Unknown

Invetigational Site, Buenos Aires

Investigational Site, Santiago

Investigational Site, Talcahuano

Investigational Site, Temuco

Investigational Site, Valdivia

Investigational Site, Valparaíso

Investigational Site, Pradesh

Investigational Site, Lima

X5000JQB

Investigational Site, Córdoba

X5000JRD

INvestigational Site, Córdoba

X5004CDT

Investigational Site, Córdoba

E3100BBJ

Investigational Site, Entre Ríos

Investigational Site, Paraná

S152EDD

Investigational Site, Granadero Baiggoria

S2152EDD

Investigational Site, Santa Fe

S3000EOY

Investigational Site, Santa Fe

3 Piso

Investigational Site, Santiago

4 Piso

Investigational Site, Santiago

Of.5

Inestigational Site, Valdivia

D-52057

Investigational Site, Aachen

D-12351

Investigational Site, Berlin

06120

Investigational Site, Halle

ut3

Investigational Site, Seregelyesi

ut.62

Investigational Site, Sostoi

u.68

Investigational Site, Szent Instvan

u.2

Investigational Site, Vasvari Pal

LV-5417

Investigational Site, Daugavpils

Investigational Site, Liepāja

LV-1002

Investigational Site, Latvia

LV-1001

Investigational Site, Riga

CP44280

Investigational Site, Chihuahua City

Investigational Site, Jalisco

15-540

Investigator Site, Bialystok

43-360

Investigational Site, Bystra

32-500

Investigational Site, Chrzanów

31-066

Investigational Site, Krakow

31-202

Investigational Site, Krakow

Investigtional Site, Krakow

31-531

Investigational Site, Krakow

90-153

Investigational Site, Lodz

91-520

Investigational Site, Lodz

20-954

Investigational Site, Lublin

60-531

Investigational Site, Poznan

60-569

Investigational Site, Poznan

96-100

Investigational Site, Skierniewice

00-909

Inestigational Site, Warsaw

Investigational Site, Warsaw

01-138

Investigational Site, Warsaw

02-097

Investigational Site, Warsaw

04-073

Investigational Site, Warsaw

43-365

Investigational Site, Wilkowice-Bystra

50-417

Investigational Site, Wroclaw

41-800

Investigational Site, Zabrze

41-803

Investigational Site, Zabrze

010825

Investigational Site, Bucharest

030303

Investigational Site, Bucharest

050098

Investigational Site, Bucharest

01133

Investigational site, Kyiv

03115

Investigational Site, Kyiv

03680

Investigational site, Kyiv

Sponsors
All Listed Sponsors
lead

Forest Laboratories

INDUSTRY