a study to assess efficacy and safety of iv/po moxifloxacin in the treatment of csssis

Conditions: Infectious Diseases

Summary: 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 \ 12.000/mmc 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 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

Keywords: complicated skin and skin structure infections csssi