infected skin skin infection
Conditions
Interventions
The Test Treatment is sequential (intravenous/oral) moxifloxacin 400 mg once
daily.
The Comparator Treatment is intravenous piperacillin/tazobactam 4.0/0.5 g every
8 hours followed by oral amoxicill
Sponsors
Bayer
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent. 2. Men or women of age => 18 years of age with a diagnosis of bacterial skin and skin structure infection that requires a. Hospitalization or b. Initial parenteral therapy for at least 48 hours and c. Meets at least one of the following criteria: - Involvement of deep soft tissue (eg, 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 (ie, congestive heart disease), diabetes mellitus, hepatic (ie, cirrhosis or another form of chronic liver disease), immunologic, renal disease, respiratory, transplantation or vascular disease. 3. Duration of infection 1 c
Exclusion criteria
Exclusion criteria: 1. 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). 2. The following skin and skin structure infections: a. Necrotizing fasciitis including Fournier*s gangrene, ecthyma gangrenosum, streptococcal necrotizing fasciitis and clostridial necrotizing fasciitis. b. Burn wound infections. c. Secondary infections of a chronic skin disease (eg, atopic dermatitis). d. Infection of prosthetic materials (eg, subcutaneous tissue infection related to a central venous catheter or permanent cardiac pacemaker battery pack). Subjects with removal of a prosthetic device involved in an infection should not be included. e. Infections where a surgical procedure alone is definitive therapy. f. Subjects with uncomplicated skin and skin structure infections including folliculitis and furunculosis, carbunculosis, simple abscesses and superficial cellulitis. 3. Known hypersensitivity to quinolones and/or any type of beta-lactam antibiotic drugs or any of the excipients. 4. Previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin-clavulanic acid. 5. Severe, life threatening disease with a life expectancy of less than 2 months. 6. Immunosuppression including: a. Known neutropenia (neutrophil count = 2 weeks) with known immunosuppressant therapy (including treatment with > 15 mg/day of systemic prednisone or equivalent). e. Any other congenital or acquired immune defect or immunosuppression. 7. Known severe hepatic insufficiency (Child Pugh C) or transaminases increase > 5 fold upper limit of normal (ULN). 8. 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. 18. Infection known to be due to a MRS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter for this trial is clinical response at the Test-of-Cure Visit 14-28 days after last dose of study medication. The blinded assessment will be considered as the primary evaluation for the clinical response at the TOC visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Clinical response assessed by the investigator on treatment Day 3-5. • Clinical response assessed by the investigator at the End-of -Therapy (EOT). • Clinical response assessed by the investigator at the TOC visit. • Bacteriological response at Day 3-5, at EOT and at the TOC visit. | — |
Countries
Netherlands
Outcome results
None listed