Clinical course of C.difficile infection
Research type
Research Study
Full title
Clinical course of Patient's infection determined by Laboratory Diagnostic Assays for C. difficile Detection from Faecal Samples (PLaciD)
IRAS ID
108081
Contact name
Kerrie Davies
Contact email
Sponsor organisation
University of Leeds
Research summary
Clostridium difficile is a well-recognised cause of hospital-acquired infections; C. difficile is the aetiological agent of pseudomembranous colitis and is implicated in most cases of antibiotic associated diarrhoea. Symptoms can range from mild to severe diarrhoea and may even be fatal; either from C. difficile Infection (CDI) alone, or due to exacerbation of co-morbidities. Some patients may be asymptomatic.
Laboratory diagnosis has historically largely relied on the detection of C. difficile toxins within a faecal sample by direct cytotoxin assay or immunoassays (EIA). Previous studies have highlighted the poor performance of these immunoassays and alternative methods of detection have now been introduced, including detection of C. difficile specific glutamate dehydrogenase (GDH) a cell-surface enzyme, and molecular assays for the detection of C. difficile toxin genes. Combinations of tests (algorithms) have recently been evaluated and GDH/toxin is now advocated by the UK Department of Health. This algorithm can differentiate three patient groups, CDI likely present (GDH positive/toxin positive), C. difficile present (GDH positive/toxin negative) and CDI/C. difficile not present. The GDH positive/toxin negative patient group (potential C. difficile excretors) may represent a potential cross-infection risk. Crucially, there is little evidence of how each of the currently available laboratory markers of C. difficile relate to the clinical course of the infection.
The role of diagnostic assays in detecting potential C. difficile excretors and asymptomatic carriage, along with their use as admission surveillance tools is as yet unclear. This study aims to determine the time course of C. difficile infection as detected by different diagnostic assays for C. difficile by serial sampling and match this with severity markers. This will provide information on the optimal timing of C. difficile tests for patients who are symptomatic or asymptomatic. Comparisons of the types of C. difficile isolated from these different patient groups will provide invaluable information on the relatedness of isolates between these groups.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
13/NE/0255
Date of REC Opinion
18 Oct 2013
REC opinion
Further Information Favourable Opinion