Comparative Study of Coadministered Ceftaroline Fosamil and NXL104 vs. Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infections

PHASE2CompletedINTERVENTIONAL
Enrollment

217

Participants

Timeline

Start Date

December 31, 2010

Primary Completion Date

March 31, 2012

Study Completion Date

July 31, 2012

Conditions
Urinary Tract Infections
Interventions
DRUG

Ceftaroline fosamil and NXL104 (q8h)

600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 8 hours (q8h);

DRUG

Ceftaroline fosamil and NXL104 (q12h)

600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 12 hours (q12h);

DRUG

Doripenem

500 mg doripenem IV q8h;

DRUG

Placebo

On CXL-MD-02, there were (3) treatment arms (meaning a subject could be randomized to 1 of 3 possible treatment regimens). Each treatment arm contained 1 or 2 placebo doses of IV saline in order to preserve the blind.

Trial Locations (50)

1407

Investigational Site, Sofia

1431

Investigational Site, Sofia

1606

Investigational Site, Sofia

4002

Investigational Site, Plovdiv

7002

Investigational Site, Rousse

9002

Investigational Site, Varna

10117

Investigational Site, Berlin

21280

Investigational Site, Diyarbakır

21287

Investigational Site, Baltimore

26480

Investigational Site, Eskişehir

32429

Investigational Site, Minden

32504

Investigational Site, Pensacola

33098

Investigational Site, Paderborn

34125

Investigational Site, Kassel

35040

Investigational Site, Izmir

35340

Investigational Site, Izmir

35385

Investigational Site, Giessen

48202

Investigational Site, Detroit

79106

Investigational Site, Freiburg im Breisgau

79379

Investigational Site, Müllheim

82152

Investigational Site, Planegg

91942

Investigational Site, La Mesa

92120

Investigational Site, San Diego

105077

Investigational Site, Moscow

105425

Investigational Site, Moscow

111123

Investigational Site, Moscow

119049

Investigational Site, Moscow

193312

Investigational Site, Saint Petersburg

194044

Investigational Site, Saint Petersburg

194291

Investigational Site, Saint Petersburg

194354

Investigational Site, Saint Petersburg

195067

Investigational Site, Saint Petersburg

196247

Investigational Site, Saint Petersburg

198205

Investigational Site, Saint Petersburg

199178

Investigational Site, Saint Petersburg

214018

Investigational Site, Smolensk

344022

Investigational Site, Rostov-on-Don

Unknown

Investigational Site, Beirut

15-950

Investigational Site, Bialystok

43-316

Investigational Site, Bielsko-Biala

42-200

Investigational Site, Częstochowa

40-073

Investigational Site, Katowice

40-752

Investigational Site, Katowice

90-153

Investigational Site, Lodz

43-100

Investigational Site, Tychy

03-401

Investigational Site, Warsaw

05-200

Investigational Site, Wołomin

50-349

Investigational Site, Wroclaw

22-400

Investigational Site, Zamość

119992-119435

Investigational Site, Moscow

Sponsors
All Listed Sponsors
lead

Forest Laboratories

INDUSTRY