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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Clavulanic Acid; Clavulanic Acids; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

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 pressuredecreased 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