Comparing different treatment schedules of ceftaroline; version 1

• Research type

  Research Study

• Full title

  A Phase I, Single Centre, Randomised, Double-blind, Placebo-controlled Parallel Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ceftaroline after Different Intravenous Dose Regimens of Ceftaroline Fosamil to Healthy Subjects (12-009)

• IRAS ID

  105618

• Contact name

  Elizabeth Tranter

• Sponsor organisation

  AstraZeneca Clinical Pharmacology Alliance

• Eudract number

  2011-000409-27

• ISRCTN Number

  xx

• Research summary

  Ceftaroline fosamil is an antibiotic that??s licensed in the USA to treat skin infections and chest infections. The recommended dose of ceftaroline given to patients in the USA is 600 mg given, every 12 h, as a slow injection into a vein over 1 h. We??re doing this study to test blood levels, urine levels and side effects of ceftaroline given according to a new treatment schedule. 40 healthy men and women, aged 18??55 years, will take part. They will receive repeated injections of 600 mg ceftaroline or placebo, as follows. * Group A: 20 volunteers will receive injections over 1 h: single injections on Days 1 and 8, and twice-daily injections on Days 2??7. * Group B: 20 volunteers will receive injections over 2 h: single injections on Days 1 and 8, and 3 daily injections on each of Days 2??7.Participants will take up to 7 weeks to finish the study. Participants will attend the ward for screening, follow-up, and one study session (a stay of 9 nights). The study will take place at 1 centre in London. We'll recruit participants by advertising (newspaper, radio, and websites), word of mouth, from volunteer databases, and our website. A pharmaceutical company, AstraZeneca, is funding the study.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  12/LO/0752

• Date of REC Opinion

  7 Jun 2012

• REC opinion

  Favourable Opinion