PMID- 21115455
OWN - NLM
STAT- MEDLINE
DCOM- 20110314
LR  - 20231213
IS  - 1460-2091 (Electronic)
IS  - 0305-7453 (Linking)
VI  - 65 Suppl 4
DP  - 2010 Nov
TI  - 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.
PG  - iv53-iv65
LID - 10.1093/jac/dkq255 [doi]
AB  - OBJECTIVES: New therapies for complicated skin and skin structure infections 
      (cSSSIs) are needed because of significant morbidity and increasing antimicrobial 
      resistance. Methicillin-resistant Staphylococcus aureus (MRSA) is a common cause 
      of cSSSIs. Ceftaroline fosamil, a novel parenteral cephalosporin with excellent 
      in vitro activity against Gram-positive pathogens, including MRSA, and many 
      Gram-negative pathogens, was evaluated as therapy for cSSSIs in a multinational 
      Phase III study. The primary study objective was to determine non-inferiority 
      [lower limit of 95% confidence interval (CI), -10%] in the clinical cure rate of 
      ceftaroline fosamil monotherapy to that achieved with vancomycin plus aztreonam 
      combination therapy in the clinically evaluable (CE) and modified intent-to-treat 
      (MITT) analysis populations. METHODS: Adult patients with cSSSIs requiring 
      intravenous therapy received 600 mg of ceftaroline fosamil every 12 h or 1 g of 
      vancomycin plus 1 g of aztreonam every 12 h for 5-14 days (randomized 1 : 1). 
      Clinical and microbiological response, adverse events (AEs) and laboratory tests 
      were assessed. Registration number NCT00423657 
      (http://clinicaltrials.gov/ct2/show/NCT00423657). RESULTS: The study enrolled 694 
      patients, 348 of whom received ceftaroline fosamil and 346 of whom received 
      vancomycin plus aztreonam. The treatment groups had comparable baseline 
      characteristics. Clinical cure rates for the ceftaroline fosamil and vancomycin 
      plus aztreonam groups were similar in the CE (92.2%, 271/294 versus 92.1%, 
      269/292; 95% CI, -4.4, 4.5) and MITT (85.1%, 291/342 versus 85.5%, 289/338; 95% 
      CI, -5.8, 5.0) populations, respectively. MRSA cSSSIs were cured in 91.4% (64/70) 
      of patients in the ceftaroline fosamil group and 93.3% (56/60) of patients in the 
      vancomycin plus aztreonam group. The microbiological success rate in the 
      microbiologically evaluable population was 92.9% and 95.0% for ceftaroline 
      fosamil and vancomycin plus aztreonam, respectively. Ceftaroline fosamil and 
      vancomycin plus aztreonam had similar rates of AEs, serious AEs and 
      discontinuations because of an AE. The most common AEs for ceftaroline fosamil 
      and vancomycin plus aztreonam included diarrhoea (6.5% versus 4.4%), nausea (6.2% 
      versus 5.6%), headache (5.3% versus 5.3%) and pruritus (3.8% versus 8.3%), 
      respectively. CONCLUSIONS: Ceftaroline fosamil demonstrated high clinical cure 
      and microbiological success rates, was efficacious against cSSSIs caused by MRSA 
      and other common cSSSI pathogens and was generally well tolerated. Monotherapy 
      with ceftaroline fosamil has the potential to provide an alternative treatment 
      for cSSSIs.
FAU - Wilcox, Mark H
AU  - Wilcox MH
AD  - Department of Microbiology, Leeds Teaching Hospitals & University of Leeds, 
      Leeds, UK. mark.wilcox@leedsth.nhs.uk
FAU - Corey, G Ralph
AU  - Corey GR
FAU - Talbot, George H
AU  - Talbot GH
FAU - Thye, Dirk
AU  - Thye D
FAU - Friedland, David
AU  - Friedland D
FAU - Baculik, Tanya
AU  - Baculik T
CN  - CANVAS 2 investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT00423657
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - J Antimicrob Chemother
JT  - The Journal of antimicrobial chemotherapy
JID - 7513617
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Cephalosporins)
RN  - 6Q205EH1VU (Vancomycin)
RN  - G2B4VE5GH8 (Aztreonam)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Bacterial Agents/administration & dosage/adverse 
      effects/pharmacology/*therapeutic use
MH  - Aztreonam/administration & dosage/adverse effects/therapeutic use
MH  - Cephalosporins/administration & dosage/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Humans
MH  - Methicillin-Resistant Staphylococcus aureus/drug effects
MH  - Middle Aged
MH  - Skin Diseases, Bacterial/*drug therapy/microbiology
MH  - Soft Tissue Infections/*drug therapy/microbiology
MH  - Staphylococcal Infections/drug therapy/microbiology
MH  - Treatment Outcome
MH  - Vancomycin/administration & dosage/adverse effects/therapeutic use
MH  - Young Adult
MH  - Ceftaroline
FIR - Manos, Paul
IR  - Manos P
FIR - Lee, Patrick
IR  - Lee P
FIR - Bush, Larry
IR  - Bush L
FIR - Desanto, Joseph
IR  - Desanto J
FIR - Jauregui-Peredo, Luis
IR  - Jauregui-Peredo L
FIR - Sheftel, Thomas
IR  - Sheftel T
FIR - Pullman, John
IR  - Pullman J
FIR - Schrock, Christian
IR  - Schrock C
FIR - Standiford, Harold
IR  - Standiford H
FIR - Mason, Rodney
IR  - Mason R
FIR - Guetzkow, James
IR  - Guetzkow J
FIR - Lucasti, Christopher
IR  - Lucasti C
FIR - Surber, Joseph
IR  - Surber J
FIR - Lee, Soledad
IR  - Lee S
FIR - Samonte, Vladimir
IR  - Samonte V
FIR - Rodriguez, Claudia G
IR  - Rodriguez CG
FIR - Altclas, Javier D
IR  - Altclas JD
FIR - Bergallo, Carlos E
IR  - Bergallo CE
FIR - Mastruzzo, Maria A
IR  - Mastruzzo MA
FIR - Morera, Graciana I
IR  - Morera GI
FIR - Prieto, Sergio E
IR  - Prieto SE
FIR - Remolif, Christian G
IR  - Remolif CG
FIR - Timmerman, Artur
IR  - Timmerman A
FIR - Freire, Antonio
IR  - Freire A
FIR - Calvo, Mario
IR  - Calvo M
FIR - Chain, Carolina
IR  - Chain C
FIR - Llancaqueo, Alvaro
IR  - Llancaqueo A
FIR - Amaya, Gerardo
IR  - Amaya G
FIR - Rodriguez, Eduardo
IR  - Rodriguez E
FIR - Osipov, Igor S
IR  - Osipov IS
FIR - Konychev, Alexander V
IR  - Konychev AV
FIR - Shlyapnikov, Sergey A
IR  - Shlyapnikov SA
FIR - Shulutko, Alexander M
IR  - Shulutko AM
FIR - Zuckerman, Jane
IR  - Zuckerman J
FIR - Bachter, Dieter
IR  - Bachter D
FIR - Kohl, Peter
IR  - Kohl P
FIR - Schilling, Martin
IR  - Schilling M
FIR - Kulig, Jan
IR  - Kulig J
FIR - Hartwich, Artur
IR  - Hartwich A
FIR - Szyber, Piotr
IR  - Szyber P
FIR - Rudzki, Slawomir
IR  - Rudzki S
FIR - Kolomecki, Krzysztof
IR  - Kolomecki K
FIR - Drazkiewicz, Marek
IR  - Drazkiewicz M
FIR - Gutowska-Jablonska, Malgorzata
IR  - Gutowska-Jablonska M
FIR - Majewski, Waclaw
IR  - Majewski W
FIR - Trautinger, Franz
IR  - Trautinger F
FIR - Schandalik, Rudolf
IR  - Schandalik R
FIR - Pavars, Andrejs
IR  - Pavars A
FIR - Lovcinoskis, Victors
IR  - Lovcinoskis V
FIR - Gardovskis, Janis
IR  - Gardovskis J
FIR - Hartmane, Ilona
IR  - Hartmane I
FIR - Zarembo, Edgars
IR  - Zarembo E
FIR - Bezrodny, Boris G
IR  - Bezrodny BG
FIR - Datsenko, Oleksiy B
IR  - Datsenko OB
FIR - Stasyshyn, Oleksandra V
IR  - Stasyshyn OV
FIR - Ganzhyi, Volodymyr V
IR  - Ganzhyi VV
EDAT- 2010/12/09 06:00
MHDA- 2011/03/15 06:00
CRDT- 2010/12/01 06:00
PHST- 2010/12/01 06:00 [entrez]
PHST- 2010/12/09 06:00 [pubmed]
PHST- 2011/03/15 06:00 [medline]
AID - dkq255 [pii]
AID - 10.1093/jac/dkq255 [doi]
PST - ppublish
SO  - J Antimicrob Chemother. 2010 Nov;65 Suppl 4:iv53-iv65. doi: 10.1093/jac/dkq255.