Complicated Skin and Skin Structure Infections (cSSSI) MedDRA version: 8.1 Level: LLT Classification code 10052891 Term: Skin bacterial infection
Conditions
Sponsors
Cerexa, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age greater than or equal to 18 years 2. Skin and skin structure infection (SSSI) that meets EITHER of the following criteria:Involves deeper soft tissue or requires significant surgical intervention, such as a wound infection (surgical or traumatic), a major abscess, an infected ulcer, or deep and extensive cellulitisORCellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease (PVD) 3. Three or more of the following clinical signs: · Purulent or seropurulent drainage or discharge · Erythema · Fluctuance · Heat or localized warmth · Pain or tenderness to palpation · Fever greater than 38ºC oral (> 38.5ºC rectally or tympanically) or hypothermia (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of any hypersensitivity or allergic reaction to any ß-lactam antibiotic 2. History of any hypersensitivity or allergic reaction to vancomycin or aztreonam 3. Past or current history of epilepsy or seizure disorder, excluding well-documented febrile seizure of childhood 4. More than 24 hours of treatment with a non-study antimicrobial (other than topical antibiotics) for the treatment of current cSSSI within 96 hours prior to randomization. EXCEPTION: Subjects may be eligible if they meet BOTH of the following conditions: · Clinical evidence of failure following at least 48 hours of prior systemic antibiotic therapy AND · Microbiological evidence of failure 5. Failure of vancomycin or aztreonam as therapy for cSSSI, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam 6. Uncomplicated SSSI such as simple abscess, impetiginous lesions, superficial cellulitis, furunculosis, carbunculosis, or folliculitis. Skin and skin structure infections with a high cure rate after surgical incision alone or after aggressive local skin care (e.g., surgical site infection with a margin of less than 5 cm of surrounding cellulitis). 7. Skin and skin structure infection with ANY of the following characteristics:· -Known or suspected anaerobic pathogens (e.g., perirectal abscess)· -Known or suspected fungal, parasitic, or viral pathogens· -Known or suspected Pseudomonas aeruginosa as a contributing pathogen· -Involving a decubitus ulcer· -Involving a diabetic foot ulcer or an ulcer associated with PVD that has the following characteristics: o Accompanied with osteomyelitis o Likely to require amputation within 60 days o Likely to require revascularization within 60 days -Requiring significant surgical intervention that cannot be performed within 48 hours after initiating study drug therapy. -Cases of cellulitis with a surface area less than 10 cm2 or a history consistent with clinical improvement or stabilization. -Involving a third-degree burn or a burn covering more than 5% of total body surface area· Involving an underlying inflammatory skin disease that may obscure determination of response -Involving human or animal bites (infections associated with arthropod bites may be allowed) -Involving a rapidly necrotizing process, such as necrotizing fasciitis· -Involving gangrene of any etiology -Complicated by the presence of prosthetic materials that will not be removed, such as central venous catheters, permanent cardiac pacemaker battery packs, or joint replacement prostheses -Likely to require amputation 8. Known or suspected endocarditis, osteomyelitis, or septic arthritis 9. Requirement for concomitant antibacterial or systemic antifungal therapy for any reason EXCEPTIONS: topical antiseptics (e.g., povidone-iodine [Betadine™], chlorhexidine [Hibiclens™], and alcohol and soaps for wound care), topical antifungal therapy, or a single oral dose of any antifungal for treatment of vaginal candidiasis are allowed. 10. Probenecid administration within 3 days prior to initiation of study drug or requirement for concomitant probenecid administration 11. Infections or conditions requiring concomitant systemic corticosteroid therapy at a dose equivalent to or greater than prednisone 40 mg per day 12. Severely impaired renal function (CrCl < 30 mL/min) estimated by the Cockroft-Gault formula 13. Evidence of significant hepa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the non-inferiority in clinical cure rate of ceftaroline treatment compared with that of vancomycin plus aztreonam treatment at the Test of Cure (TOC) visit in Clinically Evaluable (CE) and Clinically Modified Intent-to-Treat (cMITT) populations of adult subjects with cSSSI.;Secondary Objective: · Determine the non-inferiority in microbiologic success (eradication or presumed eradication) rate of ceftaroline treatment compared with that of vancomycin plus aztreonam treatment at the TOC visit · Evaluate the clinical response at the End-of-Therapy (EOT) visit · Evaluate the clinical and microbiological response by pathogen at the TOC visit · Evaluate clinical relapse at the Late Follow-up visit (LFU) visit · Evaluate the microbiological re-infection or recurrence at the LFU visit · Evaluate safety;Primary end point(s): The primary efficacy outcome measure is the per subject clinical cure at the Test-of-Cure (TOC) visit in the Clinically Evaluable (CE) and Clinical Modified Intent-to-Treat (cMITT) populations. Secondary efficacy endpoints are: Per-subject clinical cure rate at the EOT visit in the CE population Per-subject clinical cure rate at the EOT visit in the cMITT population Per-subject microbiological response at the TOC visit in the microbiological Modified intent-to-Treatment (mMITT) population Per-subject microbiological response at the TOC visit in the Microbiologically Evaluable (ME) population Per-subject relapse at the LFU visit in those subjects who were clinically cured at the TOC visit Per-subject re-infection or recurrence at the LFU visit in those subjects who had a favourable microbiological outcome (eradication or presumed eradication) at the TOC visit. Safety Endpoints are: Adverse Events Serious Adverse Events Physical Examinations Vital Signs ECG’s Urinalysis Hematology Serum Chemistries Concomitant Medications Concomitant Antimicrobials | — |
Countries
Austria, Latvia, United Kingdom
Outcome results
None listed