Conditions: Bacterial Infections
Keywords: Abscess Antibacterial Antibiotic Antimicrobial Bacterial infection, skin Ceftaroline Ceftaroline acetate Cellulitis Cephalosporin Complicated skin and skin structure infection (cSSSI) cSSSI Intravenous Methicillin-resistant Staphylococcus Aureus (MRSA) PPI-0903 Prodrug Skin disease, bacterial Skin infection Staphylococcal skin infection Staphylococcus aureus Streptococcal skin infection Surgical site infection TAK-599
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 680
Healthy volunteers: no

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

Detailed description:
Additional purpose of this study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.

Arms:
arm 1: Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours. arm 2: Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.

Interventions: intervention 1: ceftaroline intervention 2: vancomycin plus aztreonam intervention 3: Placebo
Intervention descriptions: intervention 1: 600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days intervention 2: vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days. intervention 3: Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.

Protocol document: