Integrated safety summary of CANVAS 1 and 2 trials: Phase III, randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections

2010 ◽  
Vol 65 (Supplement 4) ◽  
pp. iv67-iv71 ◽  
Author(s):  
M. L. Corrado
Keyword(s):  
Phase Iii ◽  
Double Blind ◽  
Ceftaroline Fosamil ◽  
Skin Structure ◽  
Complicated Skin

scholarly journals Phase 2 Study of Ceftaroline versus Standard Therapy in Treatment of Complicated Skin and Skin Structure Infections

2007 ◽  
Vol 51 (10) ◽  
pp. 3612-3616 ◽  
Author(s):  
George H. Talbot ◽  
Dirk Thye ◽  
Anita Das ◽  
Yigong Ge
Keyword(s):  
Success Rate ◽  
Standard Therapy ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Tolerability Profile ◽  
Clinical Relapse ◽  
Cure Rate ◽  
Ceftaroline Fosamil ◽  
Skin Structure ◽  
Complicated Skin

ABSTRACT Ceftaroline, the bioactive metabolite of ceftaroline fosamil (previously PPI-0903, TAK-599), is a broad-spectrum cephalosporin with potent in vitro activity against multidrug-resistant gram-positive aerobic pathogens, including methicillin-resistant Staphylococcus aureus. A randomized, observer-blinded study to evaluate the safety and efficacy of ceftaroline versus standard therapy in treating complicated skin and skin structure infections (cSSSI) was performed. Adults with cSSSI, including at least one systemic marker of inflammation, were randomized (2:1) to receive intravenous (i.v.) ceftaroline (600 mg every 12 h) or i.v. vancomycin (1 g every 12 h) with or without adjunctive i.v. aztreonam (1 g every 8 h) for 7 to 14 days. The primary outcome measure was the clinical cure rate at a test-of-cure (TOC) visit 8 to 14 days after treatment. Secondary outcomes included the microbiological success rate (eradication or presumed eradication) at TOC and the clinical relapse rate 21 to 28 days following treatment. Of 100 subjects enrolled, 88 were clinically evaluable; the clinical cure rate was 96.7% (59/61) for ceftaroline versus 88.9% (24/27) for standard therapy. Among the microbiologically evaluable subjects (i.e., clinically evaluable and having had at least one susceptible pathogen isolated at baseline), the microbiological success rate was 95.2% (40/42) for ceftaroline versus 85.7% (18/21) for standard therapy. Relapse occurred in one subject in each group (ceftaroline, 1.8%; standard therapy, 4.3%). Ceftaroline exhibited a very favorable safety and tolerability profile, consistent with that of marketed cephalosporins. Most adverse events from ceftaroline were mild and not related to treatment. Ceftaroline holds promise as a new therapy for treatment of cSSSI and other serious polymicrobial infections.

scholarly journals Telavancin versus Standard Therapy for Treatment of Complicated Skin and Skin Structure Infections Caused by Gram-Positive Bacteria: FAST 2 Study

2006 ◽  
Vol 50 (3) ◽  
pp. 862-867 ◽  
Author(s):  
Martin E. Stryjewski ◽  
Vivian H. Chu ◽  
William D. O'Riordan ◽  
Brian L. Warren ◽  
Lala M. Dunbar ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Clinical Success ◽  
Therapy Group ◽  
Success Rates ◽  
Standard Therapy Group ◽  
Gram Positive ◽  
Double Blind ◽  
Skin Structure ◽  
Complicated Skin ◽  
Cure Rates

ABSTRACT Telavancin is a bactericidal lipoglycopeptide with a multifunctional mechanism of action. We conducted a randomized, double blind, active-control phase II trial. Patients ≥18 years of age with complicated skin and skin structure infections caused by suspected or confirmed gram-positive organisms were randomized to receive either telavancin at 10 mg/kg intravenously every 24 h (q24h) or standard therapy (antistaphylococcal penicillin at 2 g q6h or vancomycin at 1 g q12h). A total of 195 patients were randomized and received at least one dose of study medication. Clinical success rates were similar in all analysis populations at test of cure. In microbiologically evaluable patients with Staphylococcus aureus at baseline (n = 91), 96% of the telavancin group and 90% of the standard-therapy group were cured. Among patients with methicillin-resistant S. aureus (MRSA) at baseline (n = 45), clinical cure rates were also 96% for telavancin and 90% for standard therapy. Microbiologic eradication in patients with S. aureus infection was better with telavancin compared to standard therapy (92% versus 78%, P = 0.07) and significantly better in patients with MRSA (92% versus 68%; P = 0.04). Therapy was discontinued for an adverse event (AE) in 6% and 3% of the patients receiving telavancin and standard therapy, respectively. Except for two cases of rash in the telavancin group, these AEs were similar in type and severity in the two groups. The overall incidences and severities of AEs and laboratory abnormalities were similar between the two groups. These data support the ongoing studies assessing the efficacy and safety of telavancin in the treatment of serious gram-positive infections, particularly involving MRSA.

scholarly journals Prospective Study of the Wilson Severity-of-Illness Scoring System for Complicated Skin and Skin Structure Infections

2012 ◽  
Vol 57 (1) ◽  
pp. 647-650 ◽  
Author(s):  
George H. Talbot ◽  
Tanya O'Neal ◽  
Anita F. Das ◽  
Dirk Thye
Keyword(s):  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Severity Of Illness ◽  
Cure Rate ◽  
Two Phase ◽  
Ceftaroline Fosamil ◽  
Risk Class ◽  
Skin Structure ◽  
Complicated Skin ◽  
Cure Rates

ABSTRACTWilson et al. (Am. J. Surg.185:369–375, 2003) developed a disease severity classification system for use in complicated skin and skin structure infections (cSSSI). Two phase 3 trials of ceftaroline fosamil in cSSSI provided the opportunity to evaluate the association between Wilson Severity Risk Class and clinical cure rates. Our analyses did not confirm that an association exists between Wilson Severity Risk Class and clinical cure rate and, thus, did not validate its predictive utility.

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