Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection

Inclusion Criteria

• Written informed consent
• Men or women of 18 years and above with a diagnosis of bacterial skin and skin structure infection that requires
• Hospitalization and
• Initial parenteral therapy for at least 48 hours and
• Meets at least one of the following criteria:
• Involvement of deep soft tissue (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. An underlying disease is considered significant if it includes any of the following conditions that are present at the time of presentation: cancer (except basal- or squamous-cell cancer of the skin), cardiac (i.e., congestive heart disease), diabetes mellitus, hepatic (i.e., cirrhosis or another form of chronic liver disease), immunologic, renal disease, respiratory, transplantation or vascular disease
• Duration of infection 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 (bands) regardless of total peripheral WBC count
• C reactive protein (CRP) >20 mg/L
• Specimen obtained for culture from infected area by needle aspiration of obviously purulent material or by tissue biopsy or by curettage of the surface of ulcer within 48 hours prior to the initiation of study drug therapy
• Duration of treatment of the skin/skin structure infection is anticipated to be at least 7 days.
• Surgical drainage or debridement of infected wounds or abscesses, if necessary, have to have been completed /= 2 weeks) with known immunosuppressant therapy (including treatment with > 15 mg/day of systemic prednisone or equivalent)
• Any other congenital or acquired immune defect or immunosuppression
• Known severe hepatic insufficiency (Child Pugh C) or transaminases increase > 5 fold upper limit of normal (ULN)
• Known renal impairment with a baseline measured or calculated serum creatinine clearance 24 hours in the previous 7 days preceding study entry unless the subject showed no response or had worsening of clinical signs and symptoms despite 3 or more days of prior therapy and a culture obtained at the time of subject enrollment showed persistence of a pathogen which is susceptible to the study drugs. The prior antimicrobial therapy must not have been a fluoroquinolone or a beta lactam/beta lactamase combination
• Infection known to be due to a Methicillin-Resistant Staphylococcus Aureus (MRSA), Methicillin-Resistant Staphylococcus Epidermidis (MRSE) or Vancomycin Resistant Enterococcus (VRE) as the single isolated pathogen
• Previous enrolment in this study
• Participation in any clinical investigational drug study within 4 weeks of screening
• Previous history of seizure disorders