complicated skin and skin structure Infections MedDRA version: 8.1 Level: HLT Classification code 10040786 Term: Skin structures and soft tissue infections
Conditions
Interventions
Trade Name: Avalox 400mg/250ml Infusionslösung
Product Name: Moxifloxacin
Product Code: BAY 12-8039
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Moxifloxacin
Current Sponsor code: B
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following 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 and 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).(42) ? 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 cm from the wound edge. c. Fluctuance. d. Pain or t
Exclusion criteria
Exclusion criteria: Subjects with any of the following will be excluded from the study: 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 M
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to compare the efficacy and safety of two sequential (IV/PO) treatment regimens for the treatment of adult subjects with cSSSIs: • Moxifloxacin, 400 mg IV every 24 hours followed by moxifloxacin 400 mg PO every 24 hours. • Piperacillin/tazobactam, 4.0/0.5 g administered IV three times daily followed by oral amoxicillin/clavulanic acid tablets, 875/125 mg twice daily. Treatment duration is aimed at minimum of 7 days and a maximum of 21 days. The primary efficacy criterion for the clinical trial is the clinical response assessed by an independent data review committee (DRC), 14-28 days after the completion of study drug therapy (Test-of-Cure visit [TOC]). ;Secondary Objective: Secondary efficacy criteria are: • 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 on Day 3-5, at the EOT and TOC visit. ;Primary end point(s): The primary efficacy criterion for this trial is clinical response at the Test-of-Cure Visit 14-28 days after last dose of study medication. The blinded assessment made by the DRC will be considered as the primary evaluation for the clinical response at the TOC visit. | — |
Countries
Austria, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Spain, United Kingdom
Outcome results
None listed