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

The purpose of this study is to assess if a therapy with intravenous and oral moxifloxacin is as effective as a therapy with intravenous and oral amoxicilline/clavulanate in the treatment of complicated skin and skin structure infection.


Eligibility Criteria:
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

Exclusion Criteria:

* 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