RAPID

• Research type

  Research Study

• Full title

  A randomised placebo controlled trial of follow on Rifaximin for the prevention of relapse of Clostridium difficile associated diarrhoea.

• IRAS ID

  67974

• Contact name

  Robin Spiller

• Sponsor organisation

  University of Nottingham

• Eudract number

  2012-003205-10

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Clostridium Difficile (C.Diff.) infection is the main cause of antibiotic associated diarrhoea. It has historically mainly affects elderly hospitalised patients, although more recently a rising incidence of more virulent strains has been associated with infection in younger patients and those in the community. Clostridium difficile infection is characterised by a high incidence of recurrent infection which can have debilitating consequences on already weakened patients. There are few well designed clinical trials into this condition and treatment is largely based on experience and consensus opinion. Rifaximin is a poorly absorbed antibiotic which has been used for many years in Italy and the USA for the treatment of traveller's diarrhoea and IBS. It has an excellent safety record and has been shown to achieve high concentrations in the bowel. It has been used effectively to treat Clostridium difficile infection and has a low rate of antibiotic-resistance development. It has also been suggested as beneficial when used after an effective course of the antibiotic, metronidazole since it is said to disturb the normal gut bacteria less than metronidazole and vancomycin and hence might be predicted to reduce the incidence of relapse. We propose to test this hypothesis in our study. A reduction in recurrence rate of C Difficile from 30% to 5% would significantly reduce the burden of this disease in hospitals and the community and provide an inexpensive solution to this serious illness.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  12/EM/0292

• Date of REC Opinion

  31 Aug 2012

• REC opinion

  Further Information Favourable Opinion