Study of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam for CSSI

• Research type

  Research Study

• Full title

  A Phase III, Multicentre, Randomised, Double-Blind, Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg every 8 hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities.

• IRAS ID

  92523

• Contact name

  Matthew Dryden

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2011-004013-16

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Complicated skin and soft tissue infections (cSSTi) are common worldwide. The increasing number of Methicillin Resistant strains of Staphylococcus Aureus (MRSA) and the increase in resistance to currently available antibiotics have necessitated the development of new antibiotics. Ceftaroline fosamil is a broad spectrum antibiotic which is being developed by AstraZeneca; this study is being done to see how safe and effective ceftaroline fosamil is compared to the standard antibiotic treatment of vancomycin plus aztreonam for cSSTi. Ceftaroline fosamil is approved to treat cSSTi is the USA, but at a lower total daily dose than will be used in this study. The higher dose is being studied because difficult skin infections sometimes require higher doses. Ceftaroline fosamil is not approved in Europe and is therefore an experimental drug.Ceftaroline fosamil belongs to a class of drugs called ??cephalosporins??. It has been shown to be safe and well tolerated in clinical trials to date; its safety profile is similar to other drugs in its class. 765 adult participants will take part in this study worldwide. To be eligible, participants must have a cSSTi with evidence of systemic inflammatory response (eg. fever) or underlying comorbidities (eg. patient has existing disease such as diabetes or kidney problems). Each participant's expected to be in the study for 26-51 days. Treatment will be blinded; participants will have a 66% chance of receiving Ceftaroline fosamil and a 33% chance of receiving vancomycin plus aztreonam. Neither the participant nor the doctor will know which treatment they are receiving. Each participant will receive 5-14 days of study treatment. All study treatment will be given intravenously.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  12/SC/0007

• Date of REC Opinion

  23 Jan 2012

• REC opinion

  Favourable Opinion