NCT01281462

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

A Phase 2, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Efficacy and Safety of Intravenous Coadministered Ceftaroline Fosamil and NXL104 Versus Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study in adult subjects with complicated urinary tract infection (cUTI) comparing treatment with intravenous (IV) coadministered ceftaroline fosamil and NXL104 versus treatment with IV doripenem.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-03-01
• Completion: 2012-07-01
• First posted: 2011-01-24
• Last updated: 2014-02-03

Locations

50 sites across 7 countries: United States, Bulgaria, Germany, Lebanon, Poland, Russia, Turkey (Türkiye)