Conditions: Skin and Subcutaneous Tissue Bacterial Infections Skin Structures and Soft Tissue Infections
Keywords: Bacterial skin infection infection skin delafloxacin vancomycin aztreonam methicillin-resistant Staphylococcus aureus (MRSA) bacteria bacterial infection Anti-Infective Agents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 850
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus Aztreonam in the treatment of patients with acute bacterial skin and soft tissue infections.

Detailed description:
The purpose of this study is to determine if delafloxacin, an investigational drug, is safe and effective in the treatment of skin and nearby tissue infections compared with a combination of other antibiotics, vancomycin and aztreonam.

Arms:
arm 1: Delafloxacin 300 mg IV Q12H for 6 doses, then Delafloxacin 450 mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total arm 2: Vancomycin 15 mg/kg IV plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total (Aztreonam was discontinued as soon as possible if a gram-negative organism was not identified in baseline cultures)

Interventions: intervention 1: delafloxacin intervention 2: vancomycin intervention 3: aztreonam
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: