TEA trial version 1.0

• Research type

  Research Study

• Full title

  Temocillin use in Complicated Urinary Tract Infections due to ESBL producing and AmpC hyperproducing Enterobacteriaceae in United Kingdom

• IRAS ID

  33367

• Contact name

  Peter Hawkey

• Sponsor organisation

  Eumedica s.a

• Eudract number

  2008-005912-41

• Research summary

  Antibiotic resistance in bacteria causing urinary tract infection is a new significant problem. Some bacteria have developed mechanisms such as ESBL or AmpC that allow them to become resistant to most antibiotics that are available, and are therefore causing major therapeutic problems. Temocillin, although licensed in the UK, has not been widely used largely because of the very recent rise in these new ESBL and AmpC bacteria and a lack of UK data. There is extensive experience in Europe, particularly in Belgium, that shows that temocillin is effective in killing these resistant bacteria causing urinary tract infections. However, a lot of that information has not been collected in a systematic fashion and it is the purpose of this study to collect information on the effectiveness of temocillin in treating infections caused by these very resistant bacteria. The results of this study will be of benefit to future patients with complicated urinary tract infections as doctors in UK will have modern information demonstrating which patients will benefit most from Temocillin. The study is sponsored by Belpharma (a Belgian pharmaceutical company) which is responsible for the manufacture and selling of temocillin in the UK. Patients will be recruited in two teaching hospitals in England (Heart of England Hospital, Birmingham; and Harrogate District Hospital).

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  09/H1003/125

• Date of REC Opinion

  4 May 2010

• REC opinion

  Further Information Favourable Opinion