Does treatment delay affect symptom duration in CDI?
Research type
Research Study
Full title
Does delay in treatment initiation have an effect on duration of diarrhoea or future recurrence risk in Clostridium difficile infection (CDI)?
IRAS ID
236979
Contact name
Daniel Pickering
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
1 years, 8 months, 1 days
Research summary
Clostridium difficile infection is a disease caused by the overgrowth of bacteria in your gut, it primarily effects the elderly. Clostridium difficile infection (CDI) is usually treated with antibiotics, usually vancomycin, metronidazole or fidaxomicin. The most commonly reported symptom of CDI is diarrhoea (3 or more unformed stools a day), but perforation of the colon and death is possible in the most severe cases. In addition, patients can suffer subsequent episodes of CDI (recurrent CDI/rCDI) after successful treatment of an initial episode. Previously, a variety of reasons have been identified in causing delays in treatment initiation. These include incorrect labelling for diagnostic faecal samples and delays in obtaining samples. As well as subjecting patients to potentially unnecessary antibiotics, the role of treatment delay in symptom duration and recurrence is unclear. The current research is planning on using data generated from a previous study (14/NW/1398) to assess the effect of treatment delay on two outcomes in CDI; symptom duration and recurrence (up to 28 days after treatment completion). Patient data related to the following will be statistically analysed; age, sex, severity of CDI episode at admission, modified comorbidity score, treatment group (vancomycin/ metronidazole or fidaxomicin) and site. If treatment delay is found to have an effect on the two clinical outcomes above (symptom duration and recurrence), this could inform future clinical practice in treatment of CDI.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
18/NE/0054
Date of REC Opinion
7 Feb 2018
REC opinion
Favourable Opinion