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