CANVAS 1 and 2: Analysis of clinical response at day 3 in two phase 3 trials of ceftaroline fosamil versus vancomycin plus aztreonam in treatment of acute bacterial skin and skin structure infections

Antimicrobial Agents and Chemotherapy

Volumn 56, Issue 5, 2012, Pages 2231-2236

  Friedland, H David ^a   O'Neal, Tanya ^a   Biek, Donald ^a   Eckburg, Paul B ^a   Rank, Douglas R ^a   Llorens, Lily ^a   Smith, Alex ^a   Witherell, Gary W ^a   Laudano, Joseph B ^b   Thye, Dirk ^a  

^a Cerexa Inc   (United States)

^b FOREST RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AZTREONAM; CEFTAROLINE FOSAMIL; VANCOMYCIN;

ADULT; AGED; ARTICLE; BACTERIAL SKIN DISEASE; BITE; CELLULITIS; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; FEVER; GRAM NEGATIVE BACTERIUM; HUMAN; MAJOR CLINICAL STUDY; MALE; METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS; MONOTHERAPY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SKIN ABSCESS; SKIN INFECTION; SKIN STRUCTURE; TREATMENT OUTCOME; WOUND INFECTION;

ACUTE DISEASE; AGED; AGED, 80 AND OVER; ANTI-BACTERIAL AGENTS; AZTREONAM; BIOLOGICAL MARKERS; CEPHALOSPORINS; DRUG ADMINISTRATION SCHEDULE; FEMALE; GRAM-NEGATIVE BACTERIA; GRAM-POSITIVE BACTERIA; HUMANS; INJECTIONS, INTRAVENOUS; MALE; METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS; MIDDLE AGED; RETROSPECTIVE STUDIES; SKIN DISEASES, BACTERIAL; TREATMENT OUTCOME; VANCOMYCIN;

EID: 84860193551     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.05738-11     Document Type: Article

References (19)

1. Corey GR, et al. 2010. Integrated analysis of CANVAS 1 and 2: phase 3, multicenter, randomized, double-blind studies to evaluate the safety and efficacy of ceftaroline versus vancomycin plus aztreonam in complicated skin and skin-structure infection. Clin. Infect. Dis. 51:641-650.
2. Corey GR, et al. 2010. CANVAS 1: the first phase III, randomized, double-blind study evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J. Antimicrob. Chemother. 65(Suppl.):iv41-iv51.
3. DiNubile MJ, Lipsky BA. 2004. Complicated infections of skin and skin structures: when the infection is more than skin deep. J. Antimicrob. Chemother. 53(Suppl.):ii37-ii50.
4. Edelsberg J, et al. 2008. Clinical and economic consequences of failure of initial antibiotic therapy for hospitalized patients with complicated skin and skin-structure infections. Infect. Control Hosp. Epidemiol. 29:160-169. (Pubitemid 351269212)
5. Elston DM. 2005. Optimal antibacterial treatment of uncomplicated skin and skin structure infections: applying a novel treatment algorithm. J. Drugs Dermatol. 4(Suppl.):s15-s19.
6. Eron LJ, et al. 2003. Managing skin and soft tissue infections: expert panel recommendations on key decision points. J. Antimicrob. Chemother. 52(Suppl.):i3-i17. (Pubitemid 38008402)
7. Jawesson P. 1994. Cost-effectiveness and value of an IV switch. Pharmacoeconomics 5(Suppl.):20-26.
8. Mertz D, et al. 2009. Outcomes of early switching from intravenous to oral antibiotics on medical wards. J. Antimicrob. Chemother. 64:188-199.
9. Miettinen O, Nurminen M. 1985. Comparative analysis of two rates. Stat. Med. 4:213-226. (Pubitemid 15055349)
10. Nichols RL, Florman S. 2001. Clinical presentations of soft-tissue infections and surgical site infections. Clin. Infect. Dis. 33(Suppl.):S84-S93. (Pubitemid 32762926)
11. Noel GJ, et al. 2008. Results of a double-blind, randomized trial of ceftobiprole treatment of complicated skin and skin structure infections caused by gram-positive bacteria. Antimicrob. Agents Chemother. 52:37-44.
12. Sevinç F, et al. 1999. Early switch from intravenous to oral antibiotics: guidelines and implementation in a large teaching hospital. J. Antimicrob. Chemother. 43:601-606. (Pubitemid 29182316)
13. Snodgrass WR, Anderson T. 1937. Prontosil in the treatment of erysipelas. Br. Med. J. 2:101-104.
14. Snodgrass WR, Anderson T. 1937. Sulphanilamide in the treatment of erysipelas. Br. Med. J. 2:1156-1159.
15. Spellberg B, et al. 2009. Antimicrobial agents for complicated skin and skin structure infections: justification of noninferiority margins in the absence of placebo-controlled trials. Clin. Infect. Dis. 49:383-391.
16. Strijewski ME, et al. 2008. Televancin versus vancomycin for the treatment of complicated skin and skin-structure infections caused by grampositive organisms. Clin. Infect. Dis. 46:1683-1693.
17. U. S. Food and Drug Administration. 2010. Guidance for industry. Acute bacterial skin and skin structure infections: developing drugs for treatment. U.S. Food and Drug Administration, Rockville, MD.
18. U. S. Food and Drug Administration. 1998. Guidance for industry. Uncomplicated and complicated skin and skin structure infections-developing antimicrobial drugs for treatment. U.S. Food and Drug Administration, Rockville, MD.
19. Wilcox MH, et al. 2010. CANVAS 2: the second phase III, randomized, double-blind study evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J. Antimicrob. Chemother. 65(Suppl.):iv53-iv65.