Bezlotoxumab effect on the positivity of C.difficile toxin detection
Research type
Research Study
Full title
Investigation of the effect of addition of bezlotoxumab to C. difficile toxin positive faeces on the positivity of toxin detection assays
IRAS ID
242472
Contact name
Mark Wilcox
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
0 years, 4 months, 30 days
Research summary
Investigation of the effect of addition of bezlotoxumab to C. difficile toxin positive faeces on the positivity of toxin detection assays.
Bezlotoxumab, an antibody, works by neutralising the toxins produced by the bacteria Clostridium difficile. Patients are diagnosed as having Clostridium difficile infection by sending faecal samples to the laboratory for testing. This study aims to determine if the addition of bezlotoxumab to faecal samples will give a negative result when tested using these routine assays.
Methods:
We will collect 10 faecal samples that have previously given a positive toxin test result and add bexlotoxumab to them prior to repeating the tests.Consent from the participants is not required as we will be using residual diagnostic samples and will not be collecting any clinical data. All samples will be anonymised before being handed to the researcher. This work will be completed within 6 months.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
18/NW/0223
Date of REC Opinion
26 Mar 2018
REC opinion
Favourable Opinion