A randomised placebo controlled trial of "follow on" Rifaximin for the prevention of relapse of Clostridium associated diarrhoea (RAPID)

1st November 2012 - ongoing

Status: In Recruitment

Specialism: Lower GI.

Team: Professor Robin Spiller.

Clostridium difficile associated diarrhea (CDAD) is the most common cause of infectious diarrhea following treatment with antibiotics. Clostridium difficile, or C.diff, has also gained notoriety as a hospital ‘superbug’ because of the severity of infection that can occur with some reports of death rates as high as 10%. The infection is also difficult to clear, with 30% of those infected having a second episode, or relapse, after treatment for their first infection. Those most vulnerable to relapse are the elderly and people with other medical problems, who are also most at risk of severe consequences.

Rifaximin is an antibiotic that has been used in the USA and Italy for many years to treat traveller’s diarrhoea. It is not absorbed by the body so rarely causes side effects. Previous studies have suggested that using Rifaximin can reduce the risk of further episodes of diarrhoea after CDAD. Rifaximin is a narrow-spectrum antibiotic, meaning that it only targets a small set of bacteria, including C.diff. There is some evidence that CDAD wipes out the healthy bacteria that normally live in the patient’s colon, which would explain how it can come back. Using Rifaximin after the standard treatment of CDAD might allow the normal gut bacteria to return, preventing further relapses.

In this trial we will investigate whether treatment with Rifaximin after CDAD reduces the chances of relapse. To minimize the risk of bias this will be a randomized controlled trial where equal numbers of patients will be chosen at random to be treated with Rifaximin or a placebo. Neither researchers nor patients will know which treatment they are on until the end of the trial. Our main measure will be how many people in each group get a recurrence of diarrhoea in the 3 months after their first infection.

We will also study the bacteria in the large bowel. Using cutting edge technology in collaboration with the University of Helsinki, Finland, we will determine how many different bacteria are present in the stool of patient in the trial, and whether knowing this can help us predict the risk of relapse, or the effect of treatment.

People
Photo Name Bio
professor-robin-spiller Professor Robin Spiller Professor Spiller is Professor of Gastroenterology in the NIHR Nottingham Biomedical Research Centre at the University of Nottingham. Past Editor of Gut (2003-2009) and member of the Board of the Rome Foundation (2000-2015), he twice edited the…