Conditions: Skin and Subcutaneous Tissue Bacterial Infections
Keywords: Bacterial skin infection skin infection infection skin delafloxacin vancomycin aztreonam MRSA bacteria bacterial infection Anti-Infective Agents Anti-Bacterial Agents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 660
Healthy volunteers: no

Brief summary:
This study was designed to evaluate the efficacy of delafloxacin patients with acute bacterial skin and soft tissue infections (ABSSSI).

Detailed description:
The efficacy and safety of delafloxacin, compared to that of vancomycin plus aztreonam, will be evaluated in a population of patients with acute bacterial skin and soft tissue infections (ABSSSI), including major cutaneous abscesses, wound infections, cellulitis/erysipelas, and burn-related infections.

Arms:
arm 1: Delafloxacin 300 mg IV every 12 hours for a minimum of 10 and up to a maximum of 28 doses arm 2: Vancomycin 15 mg/kg IV plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses (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 4: Placebo
Intervention descriptions: intervention 1: Delafloxacin intervention 2: Vancomycin intervention 3: Aztreonam intervention 4: Placebo

Protocol document: