EUCLID 2
Research type
Research Study
Full title
Retrospective data collection on patients with samples recieved during the European, multi-centre, prospective, bi-annual point prevalence study of Clostridium difficile infection in hospitalised patients with diarrhoea (EUCLID2)
IRAS ID
162837
Contact name
Mark Wilcox
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
0 years, 7 months, 31 days
Research summary
Clostridium difficile is an organism which can cause a diarrhoeal illness with mild to severe symptoms. It is the commonest cause of in-patinet diarrhoea in patients in the western hemisphere and has a mortality rate of ??. The best method for laboratory diagnosis of C. difficile infection (CDI) has been debated for many years, although now there are European guidelines on the best methods to use.
The EUCLID study was set up to compare how different EU countries were diagnosing CDI, including which people they tested for the disease. The results of this study showed that lack of clinical suspicion led to 25% of all cases of CDI being 'missed'. Additionally, in those hospitals which did not use the best possible diagnostic methods cases were also missed.
The scope of the original study did not allow for collection of clinical data regarding patients outcomes/concurrent illness or severity of infection. Additonally, 10% of the C. difficile toxin positive samples came from patients under 16 years of age. There are a paucity of data regarding the role of toxin detection in paediatric patients and the status of CDI is unclear in this patient group.
The aim of this study would be to retrospectively collect data on those patients highlighted as 'missed' in the first study and compare their outcomes to patients that were correctly diagnosed (and therefore presumably treated). Addtionally we would collect data on those peadiatric patients identified as having c. difficile toxin in their sample during the first study. Although these patients did have documented diarrhoea at the time of the first study it is unknown whether they had an alternative diagnosis for their symptoms.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
15/SW/0125
Date of REC Opinion
28 Apr 2015
REC opinion
Favourable Opinion