Trial stories: Controlling Clostridioides difficile
In these trial series we dive into COMBACTE trials that are (almost) completed with insights from some of the study leads or members. During the C. difficile Awareness Month we highlight the research done within COMBACTE-CDI’s study on Epidemiology (work package 1).
C. difficile is a common human bacterium that can cause diarrhea and intestinal infections. According to the C. Diff. foundation, 2 – 5% of C. difficile becomes a serious gastrointestinal infection when individuals have been exposed to antibiotic therapy, and/or experienced a long-term hospitalization, and/or had an extended stay in a long-term care facility. But nowadays the risk of getting an infection is higher due to the increase of community acquired C. difficile infections (CDI).
COMBACTE-CDI became a part of the COMBACTE in November 2017, to focus on research on C. difficile infections (CDI). Within the project a large epidemiology study was setup across Europe to quantify the burden of Clostridium difficile Infection (incidence, distribution, recurrence, morbidity, mortality, transmission) across the whole healthcare economy. As a result the study aims to deliver a more complete understanding of CDI epidemiology via a consistent, comprehensive data collection approach that builds on and extends existing information.
COMBACTE-CDI is addressing an important gap in our knowledge about the true whole healthcare economy burdens of CDI across Europe. In order to do this, a complex coordinated project co-led by our team in Leeds has been progressing over the last 2 years. When SARS-CoV-2 has been beaten, C. difficile will still be a threat to our patients and so needs our continued attention.
Work in progress
The study is working on a couple of objectives over the last few years:
- Address the CDI epidemiology knowledge gaps in Europe, with regards to CDI incidence, by testing residual diagnostic tissue
- Characterize the strains to determine the differences in difficile strain distribution.
- Determine the rates of recurrence, morbidity and mortality according to the CDI patterns, burdens and settings by using participant data
- Identify high-risk groups for CDI, recurrence and negative outcome by using participant data
- Develop a novel way to map the relationship of CDI within the healthcare economy
Since the start in 2017 the team has come a long way in achieving their objectives. The sample period was concluded in December 2018 with 3167 samples received by the University of Leeds (central laboratory) from 12 countries across Europe. After the sample processing at Leeds, further sample testing was done by EFPIA partner, bioMerièux, followed by testing of the C. difficile isolates by the team at the National Laboratory for Health, Environment and Food in Slovenia, and whole genome sequencing carried out by another EFPIA partner, GSK.
The sample testing results were used to determine eligibility for inclusion in the case/control study which examined patient’s outcomes and risk-factors for CDI within different ‘diagnostic’ subsets of patients.
A dynamic transmission model of CDI has been developed in hospitalised patients, informed by data from the COMBACTE-CDI project, with the aim of examining the impact of testing rates and antimicrobial stewardship on the incidence of CDI nationally across Europe. Predictions from the model suggest that many European countries are significantly underestimating the incidence of CDI in hospitals through missed opportunities to test patients.
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"The burden of C. difficile infection (CDI) in Europe is poorly understood, as most countries have not implemented standardized clinical criteria or laboratory methods for CDI testing and reporting. As new interventions become available, it is critical to better estimate the incidence of disease, elucidate CDI risk factors, and describe its health and economic outcomes in order to determine optimal disease prevention and control approaches."
Jennifer Moïsi, Senior Director, Medical and Scientific Affairs, Pfizer
Ready to tick the final boxes!
First results were published in an infographic, viewable in a quick and clear overview. COMBACTE-CDI also was involved in ECCMID since 2018 with 12 total abstracts accepted presented at the conference. At the moment the COMBACTE-CDI team is busy writing the manuscript on the study findings. Within the epidemiology study 7 publications are planned for release.
Related updates
Reflecting on COMBACTE-CDI
November is Clostridioides difficile Awareness Month
