scholarly journals Risk Factors for Mixed Complicated Skin and Skin Structure Infections To Help Tailor Appropriate Empiric Therapy

2012 ◽  
Vol 13 (6) ◽  
pp. 377-382 ◽  
Author(s):  
Marya Zilberberg ◽  
Scott T. Micek ◽  
Marin H. Kollef ◽  
Ahmed Shelbaya ◽  
Andrew F. Shorr
Keyword(s):  
Risk Factors ◽  
Empiric Therapy ◽  
Skin Structure ◽  
Complicated Skin

scholarly journals PIN61 Bacteriology and Inappropriate Empiric Therapy in Mixed Complicated Skin and Skin Structure Infections

2012 ◽  
Vol 15 (4) ◽  
pp. A248
Author(s):  
M.D. Zilberberg ◽  
S.T. Micek ◽  
M. Kollef ◽  
A. Shelbaya ◽  
A.F. Shorr
Keyword(s):  
Empiric Therapy ◽  
Skin Structure ◽  
Complicated Skin ◽  
Inappropriate Empiric Therapy

Hospitalizations with healthcare-associated complicated skin and skin structure infections: Impact of inappropriate empiric therapy on outcomes

2010 ◽  
Vol 5 (9) ◽  
pp. 535-540 ◽  
Author(s):  
Marya D. Zilberberg ◽  
Andrew F. Shorr ◽  
Scott T. Micek ◽  
Joyce Chen ◽  
Andrew M. Ramsey ◽  
...  
Keyword(s):  
Empiric Therapy ◽  
Skin Structure ◽  
Complicated Skin ◽  
Healthcare Associated ◽  
Inappropriate Empiric Therapy

scholarly journals Telavancin for Acute Bacterial Skin and Skin Structure Infections, aPost HocAnalysis of the Phase 3 ATLAS Trials in Light of the 2013 FDA Guidance

2015 ◽  
Vol 59 (10) ◽  
pp. 6170-6174 ◽  
Author(s):  
Richard Pushkin ◽  
Steven L. Barriere ◽  
Whedy Wang ◽  
G. Ralph Corey ◽  
Martin E. Stryjewski
Keyword(s):  
Clinical Response ◽  
Lesion Size ◽  
Phase 3 ◽  
Two Phase ◽  
Skin Structure ◽  
Fda Guidance ◽  
Complicated Skin ◽  
Clinical Responses ◽  
Cure Rates ◽  
Post Hoc

ABSTRACTTwo phase 3 ATLAS trials demonstrated noninferiority of telavancin compared with vancomycin for complicated skin and skin structure infections. Data from these trials were retrospectively evaluated according to 2013 U.S. Food and Drug Administration (FDA) guidance on acute bacterial skin and skin structure infections. Thispost hocanalysis included patients with lesion sizes of ≥75 cm2and excluded patients with ulcers or burns (updated all-treated population;n= 1,127). Updated day 3 (early) clinical response was defined as a ≥20% reduction in lesion size from baseline and no rescue antibiotic. Updated test-of-cure (TOC) clinical response was defined as a ≥90% reduction in lesion size, no increase in lesion size since day 3, and no requirement for additional antibiotics or significant surgical procedures. Day 3 (early) clinical responses were achieved in 62.6% and 61.0% of patients receiving telavancin and vancomycin, respectively (difference, 1.7%, with a 95% confidence interval [CI] of −4.0% to 7.4%). Updated TOC visit cure rates were similar for telavancin (68.0%) and vancomycin (63.3%), with a difference of 4.8% (95% CI, −0.7% to 10.3%). Adopting current FDA guidance, this analysis corroborates previous noninferiority findings of the ATLAS trials of telavancin compared with vancomycin.

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.

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