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.
Minimum age: 18 Years.
Maximum age: N/A.
- Written informed consent
- Men or women of age >/= 18 years with a diagnosis of bacterial skin and skin
structure infection that requires
- 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
- 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
- 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