A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin and Skin Structure Infection (cSSSI)

NCT00423657 Phase 3 COMPLETED Results posted

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

Details

Lead sponsor	Forest Laboratories
Phase	Phase 3
Status	COMPLETED
Enrolment	680
Start date	2007-03
Completion	2007-12

Conditions

• Bacterial Infections

Interventions

• ceftaroline
• vancomycin plus aztreonam
• Placebo

Primary outcomes

• Clinical Cure Rate at Test of Cure (TOC) (MITT Population) — 8-15 days after last dose of study drug administration
  Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary. Failure: Requirement of alternative antimicrobial therapy for primary infection of complicated skin and skin structure infection (cSSSI) due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI. Indeterminate: Inability to determine an outcome
• The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the Clinically Evaluable (CE) Populations. — 8-15 days after last dose of study drug

Countries

United States, Argentina, Austria, Brazil, Chile, Germany, Latvia, Mexico, Poland, Russia, Ukraine, United Kingdom