Infectious Diseases

- 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 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

- Women, who are pregnant or lactating, or in whom pregnancy can not be excluded (Note: a urine pregnancy test has to be performed for all women of childbearing potential before randomization to the study drug).
- The following skin and skin structure infections:
 -- Necrotizing fasciitis including Fournier's gangrene, ecthyma gangrenosum, streptococcal necrotizing fasciitis and clostridial necrotizing fasciitis.
 -- Burn wound infections.
 -- Secondary infections of a chronic skin disease (eg, atopic dermatitis).
 -- Infection of prosthetic materials. Subjects with removal of a prosthetic device involved in an infection should not be included.
 -- Infections where a surgical procedure alone is definitive therapy.
 -- Subjects with uncomplicated skin and skin structure infections including