COMBACTE-CDI Understanding the burden of C. difficile infection
Research type
Research Study
Full title
Combatting Bacterial Resistance in Europe – Clostridium difficile Infections (COMBACTE-CDI), understanding the burden of disease
IRAS ID
244784
Contact name
Mark Wilcox
Contact email
Sponsor organisation
University of Leeds
Clinicaltrials.gov Identifier
ClinicalTrials.gov, awaiting final sign off for number
Duration of Study in the UK
2 years, 5 months, 18 days
Research summary
Research Summary
Clostridium difficile infection (CDI) is the most common cause of antibiotic associated diarrhoea in the western world. The infection causes significant diarrhoea, which in some cases can be serious and lead to secondary complications and even death. The infection is particularly an issue in elderly, frail patient, who are often already burdened with several other medical issues. Recent work has demonstrated that numerous cases are missed, either due to inadequate diagnostic tests or lack of clinical suspicion.The public-private partnership in COMBACTE-CDI will quantify the burden of CDI via a large, complex, multi-centre, multi-country study, and describe current management practices. An increased understanding of the CDI burden across Europe and better understanding of transmission of the organism will provide a basis for the further development of public health interventions and practices.
Based on a previous successful study model (EUCLID), hospitals/laboratories of interest which carry out diagnostic testing of samples from both in-patients and community patients (including Long-Term Care Facilities patients) will be approached for inclusion in the study. Samples sent to the sites on the selected study date (regardless of test requested) will be tested at a central laboratory for CDI to look for missed cases of CDI. A follow up case/control study will collect data on outcomes and risk factors. Data will be used to construct transmission models and cost effective-ness models. Ultimately, a best practice model for CDI management will be developed.
Summary of Results
Clostridium difficile infection (CDI) is one of the most prevalent healthcare-associated infections, but has more recently been recognized in people in the community (at home). CDI poses a great burden due to the debilitating effects of this diarrhoeal disease, the amount it costs to treat and the number of people who die from this infection; it therefore requires effective ways to prevent and manage the infection. Data on how much CDI there is and what types of C. difficile are circulating are limited, and studies typically only look at single countries or single parts of the healthcare system (typically hospitals). Thus, there is a lack of good data on the impact of CDI across Europe.Twelve countries took part in the project, with 3163 anonymised left over diarrhoeal poo samples submitted for testing at the central laboratory at the University of Leeds, UK. The results of this observational study did not affect the way participants were treated at the submitting laboratories. The overall amount of patients with CDI in their poo samples was lower in patients in the community than in from patients in hospital (1 in 100 compared with 4 in 100). In both settings, use of drugs to treat other infections (antibiotics) and increasing numbers of other medical conditions at the same time increased the chance that the patient got CDI. Patients in hospital with CDI were sicker and were more likely to die within 30 days of their infection than patients in hospital who did not have CDI, but this pattern was not seen in patients in the community. Due to a lack of testing, approx. 1 in 2 of all CDI patients in the community did not receive a diagnosis, compared with only 1 in 6 in the hospital setting, showing a lack of understanding of CDI as an infection that can be found outside of the hospital setting. Findings support recommendations for improving who we test and how we test patients presenting with diarrhoea in the community. Those recommendations aim to influence best practice, contributing to limiting the spread of CDI across Europe and worldwide.
Main results and URL links to publication of the key findings are also described on the Community Research and Development information Service (CORDIS) European Union research results platform: https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Furl6570.hra.nhs.uk%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbce1kSWZxhwYEboN8eA2QqV72G3XhzXeWceSfSXwknJeTn-2B07Cbq14azbmdbPCbwKg-3D-3DWwAK_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YK8gXxzIEdgLrlWiYj0EbT7aCfH1xEbB8xAlvTNOj0fWiuv6QVQH8bQCiKz-2B1R0HnElUIctIv6RXrG2k-2BAWt0z7rEGXwflGmhSaAU8dVedKiMidIABvtSnuVGOfZyPEPTpUdVpdkiKa8yrEXrgp4JYbRELzNR27tYczwf0HSy-2FWAA-3D-3D&data=04%7C01%7Capprovals%40hra.nhs.uk%7C11c56d72c35545f1a73c08d9e7c6009a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637795659861818967%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=popM7hvC6CwXiEtLKMlxY%2FFkgBW%2BVkF2Gg9rzlGV6Rk%3D&reserved=0
REC name
Wales REC 6
REC reference
18/WA/0173
Date of REC Opinion
4 May 2018
REC opinion
Favourable Opinion