Does fidaxomicin therapy reduce spread of Clostridium difficile? V9.9
Research type
Research Study
Full title
Does using fidaxomicin to treat Clostridium difficile infection (CDI) reduce the recovery of C. difficile from faeces, patient’s skin and the immediate environment compared to treatment with vancomycin or metronidazole?
IRAS ID
166078
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
"Does treating Clostridium difficile infection with fidaxomicin reduce the recovery of C. difficile from patients' faeces, skin and immediate environment, compared to treatment with vancomycin or metronidazole?"
Introduction:
Clostridium difficile is a bacterium that can cause a potentially serious diarrhoeal infection, known as CDI. It produces spores which contaminate the environment and can be passed on to others. Current efforts to prevent CDI transmission are not fully effective. It is therefore important that we find new ways to stop it being spread.
Research has shown that a new antibiotic treatment for CDI, called fidaxomicin, is more effective than older treatments at reducing the level of C. difficile in faeces, and can prevent the spores from turning back in to active bacteria. We want to investigate if CDI patients treated with fidaxomicin have less contamination of their skin and surrounding environment, than patients treated with vancomycin or metronidazole. If true, it might mean that fidaxomicin can help reduce the spread of CDI.
Methods:
The study will take place at two acute NHS trusts (Leeds Teaching Hospitals and St George's Healthcare, London). All adult patients being treated for CDI will be recruited to have their surrounding environment swabbed. This does not require informed consent. Patients will only be excluded if they are on vancomycin or metronidazole, and have had fidaxomicin in the last 12 weeks. We will recruit patients until 100 have also given informed consent for us to collect extra faecal samples and skin swabs (of the stomach, groin and hand) from them. Swabs will be taken every 2-3 days during treatment, then a week, fortnight and a month after treatment. Faecal samples will be collected as near as possible to these times.
All samples will be tested for C. difficile and results for the different drug treatments will be compared.
REC name
North West - Haydock Research Ethics Committee
REC reference
14/NW/1398
Date of REC Opinion
24 Nov 2014
REC opinion
Further Information Favourable Opinion