A Study to Assess Efficacy and Safety of IV/PO Moxifloxacin in the Treatment of cSSSIs

Inclusion Criteria

• •Written informed consent
• •Men or women of age \>/= 18 years with a diagnosis of bacterial skin and skin structure infection that requires
• •* Hospitalization
• •* Initial parenteral therapy for at least 48 hours
• •Complicated by at least one of the following criteria:
• •* Involvement of deep soft tissues (e.g. fascial, muscle layers)
• •* Requirement for a significant surgical intervention including surgical drainage, drainage procedure guided by imaging and/or debridement
• •* Association with a significant underlying disease that may complicate response to treatment.
• •* Presence of SIRS (Systemic Inflammatory Response Syndrome) defined as two or more of the following signs or symptoms: - temperature \> 38.3°C or \< 36°C - white blood cell count \> 12.000/mmc or \< 4.000 or \> 10% bands - pulse rate \> 90 beats/min - respiratory rate \> 20178 - systolic blood pressure \</= 90 mmgHg - decreased capillary refill/mottling \> 2 seconds - lactate \> 2 mmol/L - altered mental status - hyperglycemia \> 120 mg/dl or 7.7 mmol/L in the absence of diabetes - protein C (CPR) \> 20 mg/L (VR 0-5)3. Duration of infection \< 21 days
• •Diagnosis of one of the following skin and skin structure infections:
• •* major abscess(es) associates with extensive cellulitis
• •* erysipelas and cellulitis
• •* infected pressure ulcers(s)
• •* wound infections including: post surgical (surgical incision), post traumatic, human bite/clenched fist and animal bite wound and wound associated with injection drug abuse
• •* Infected ischemic ulcers with at least one of the following conditions: - Diabetes mellitus - Peripheral vascular disease - Conditions pre-disposing to pressure scores such as paraplegia or peripheral neuropathy
• •Presence of at least 3 of the following local signs and symptoms
• •* purulent drainage or discharge
• •* erythema extended \>1 cm from the wound edge
• •* fluctuance
• •* pain or tenderness to palpation
• •* swelling or induration
• •* fever defined as body temperature \> 37.5°C (axillary), \> 38°C (orally), \> 38.5°C (tympanically), or \> 39°C (rectally). OR Elevated total peripheral white blood cell (WBC) count\> 12,000/mm3 OR \> 15% immature neutrophils (blends) regardless of total peripheral WBC count
• •* C-reactive protein (CRP) \>20 mg/L