International Consensus Report Highlights Need for Improved Management of Clostridium difficile Infection (CDI) in Inflammatory Bowel Disease (IBD) Patients

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11 Apr, 2016, 10:30 GMT

AMSTERDAM, The Netherlands, April 11, 2016 /PRNewswire/ --

In patients with IBD, CDI is a key risk factor for both morbidity and mortality, with disease interactions increasing the severity of patients' colitis[1]

Results from an international consensus project involving a multidisciplinary group of clinicians have been presented today at 26th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) 2016. A current lack of data on outcomes in patients with IBD who have CDI means that appropriate choice of treatment strategy can be unclear. The consensus examines the issues impacting clinical professionals working with CDI and aims to understand the perceptions and attitudes of key stakeholders regarding best practice in the management of CDI in patients with IBD.[1]

About CDI backgrounder: http://multivu.prnewswire.com/prnehost/PIV798792AboutCDI.pdf

The Burden of CDI backgrounder: http://multivu.prnewswire.com/prnehost/PIV798792TheBurdenOfCDI.pdf

CDI is associated with high-mortality[2] and cost burden.[3] It causes or contributes to death in 2 out of 5 people who die within 3 months of diagnosis[2] and patients who acquire CDI are estimated to stay in hospital for an extra one to three weeks[4],[5] at an additional cost of up to €14,000 per patient.[6] Research has shown that IBD patients with co-existent CDI are hospitalised for substantially longer, with a median length of stay of 26 days compared with just 5 days for patients with IBD alone.[7] Overall, CDI is estimated to cost the EU €3 billion per annum and this cost is expected to almost double over the next four decades.[3]

"We know that CDI has important consequences for patients and healthcare systems, including excess morbidity, mortality and length of hospitalisation. These consequences are most pronounced in vulnerable patients, including those with inflammatory bowel disease", commented study author Professor Mark Wilcox, Professor of Medical Microbiology, Leeds Teaching Hospitals & University of Leeds.

Based on the consensus scores of 426 international healthcare professionals, including infectious disease specialists, microbiologists, and gastroenterologists, recommendations have been suggested to further develop and improve the management of CDI in patients with IBD;[1]

  • The need for a treatment strategy for CDI in IBD that is driven by risk factors for poor outcome rather than one solely defined by severity of disease
  • The need for clarity regarding clinical definitions of recurrent CDI and the need for a uniformly accepted definition of recurrent CDI in IBD patients
  • The utility of a common approach to CDI in IBD in helping to reduce variance in clinical practice between specialties and, in order to achieve this, the need for clinicians to be familiar with the role and responsibilities of other specialties in managing CDI in IBD
  • The need for higher quality evidence to inform future CDI guidelines, including clarity regarding the adjustment of immunosuppression in patients with IBD
  • The need for further data to define the place of faecal microbiota transplant in CDI patients with IBD
  • Recognition of CDI risk factors was low amongst clinicians, indicating the need for a model for scoring symptom severity.

Clinicians were asked to rate their agreement with 27 statements. Statements were submitted to respondents at conferences and congresses and, based on the resultant consensus scoring, recommendations were developed. Levels of agreement exceeded the 75% threshold for consensus for 17 out of the 27 statements, indicating strong support for the majority. Differences were observed between the perceptions of microbiologists and gastroenterologists as well as between countries.[1]

"The survey showed that members from all participating medical disciplines equally recognise the importance of infections with Clostridium difficile as critical events in the course of inflammatory bowel disease. It was astonishing to find, however, that the diagnostic and treatment strategies vary significantly between different specialists", said Lead author, Professor Dr. med. Andreas Stallmach, Department of Internal Medicine IV, Jena University Hospital. "The results of this study underline that we urgently need interdisciplinary controlled studies aiming to optimise and harmonise treatment strategies for C. difficile in patients with inflammatory bowel disease."

This project builds on a previous EU consensus report published in 2015 that put forward recommendations for the development of CDI services to help reduce transmission and recurrence and to ensure that appropriate diagnosis and treatment strategies are applied across all healthcare settings.[8]

About Clostridium difficile Infection  

'Super-bug' Clostridium difficile infection (CDI) is a recurring and preventable bacterial infection of the colon that causes severe and potentially deadly diarrhoea.[9],[10],[11] C. difficile bacteria are naturally present in the gut of up to 3% of healthy adults, usually without any problems. This is because the colonising C. difficile bacteria are 'kept under control' by the 'good bacteria'.[10] An alteration in the balance of the gut microflora, often caused by broad-spectrum antibiotics, can reduce the number of 'good' bacteria, allowing C. difficile to multiply and cause inflammation, severe diarrhoea and potentially life-threatening complications.[9],[10] CDI is one of the top ten hospital-acquired infections (HAIs) in European hospitals[12] and is estimated to be three times as deadly as MRSA.[2],[13] People in hospital with CDI are up to three times more likely to die in hospital (or within a month of infection) than those without CDI.[14],[15] Recurrence has been identified by the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) as the most important problem in the treatment of CDI,[16] and occurs in up to 25% of patients within 30 days of initial treatment with untargeted antibiotics.[17],[18],[19]

About Astellas Pharma EMEA   

Astellas Pharma EMEA operates in 40 countries across Europe, the Middle East and Africa, and is the EMEA regional business of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. The organisation's focus is to deliver outstanding R&D and marketing to continue growing in the world pharmaceutical market. Astellas presence in Europe also includes an R&D site and three manufacturing plants. The company employs over 4,500 people across the EMEA region. In 2013 Astellas was awarded SCRIP Pharmaceutical Company of the Year in recognition of its commercial success and pipeline development.

References:  

  1. Stallmach A, et al. IBD and CDI: The contrasting views of different clinical professionals. Abstract presented at ECCMID 2016.
  2. Bauer MP, Notermans DW, van Benthem BH, et al. Clostridium difficile infection in Europe: a hospital-based survey. Lancet. 2011;377:63-73.
  3. Jones AM, Kuijper EJ, Wilcox MH. Clostridium difficile: a European perspective. J Infect. 2013; 66(2):115-28.
  4. Wilcox MH, et al. Financial burden of hospital-acquired Clostridium difficile infection. J Hosp Infect. 1996;34:23-30.10.
  5. Dubberke ER, et al. Review of a current literature on the economic burden of Clostridium difficile infection. Infect Control Hosp Epidemiol. 2009;30:57-66.
  6. Magalini S, et al. An economic evaluation of Clostridium difficile infection management in an Italian hospital environment. Eur Rev Med Pharmacol Sci. 2012;16:2136-41.
  7. Jen, MH, et al. Increased health burden associated with Clostridium difficile diarrhoea in patients with inflammatory bowel disease. Alimentary pharmacology & therapeutics. 33.12 (2011): 1322-1331.
  8. Aguado, JM, et al. Highlighting clinical needs in Clostridium difficile infection: the views of European healthcare professionals at the front line. Journal of Hospital Infection. 90.2 (2015): 117-125.
  9. McMaster-Baxter NL, Musher DM. Clostridium difficile: recent epidemiologic findings and advances in therapy. Pharmacotherapy. 2007;27:1029-39.1.
  10. Sunenshine R, McDonald L. Clostridium difficile-associated disease: new challenges from an established pathogen. Cleve Clin J Med. 2006;73:187-97.
  11. Ananthakrishnan AN. Clostridium difficile infection: epidemiology, risk factors and management. Nat Rev Gastroenterol Hepatol. 2011;8:17-26.
  12. European Centre for Disease Prevention and Control (ECDC). Point prevalence survey of healthcare-associated infections and antimicrobial use in European acute care hospitals 2011-2012. Stockholm, 2013. Available from: http://ecdc.europa.eu/en/publications/Publications/healthcare-associated-infections-antimicrobial-use-PPS.pdf (last accessed April 2016).
  13. European Centre for Disease Prevention and Control/European Medicines Agency (ECDC/EMEA). Joint technical report The bacterial challenge: time to react. Stockholm: ECDC / EMEA; 2009. Available from: http://ecdc.europa.eu/en/publications/Publications/0909_TER_The_Bacterial_Challenge_Time_to_React.pdf (last accessed April 2016).
  14. Oake N, et al. The effect of hospital-acquired Clostridium difficile infection on in-hospital mortality. Arch Intern Med. 2010;170:1804-10.
  15. Hensgens MP, et al. All-Cause and disease-specific mortality in hospitalized patients with Clostridium difficile infection: a Multicenter Cohort Study. Clin Infect Dis. 2013;56:1108-16.
  16. Bauer MP, et al. European Society of Clinical Microbiology and Infectious Disease (ESCMID): treatment guidance document for Clostridium difficile-infection (CDI). Clin Micro Infect. 2009;15:1067-79.
  17. Bouza E, et al. Results of a phase III trial comparing tolevamer, vancomycin and metronidazole in patients with Clostridium difficile-associated diarrhoea. Clin Micro Infect. 2008;14(Suppl 7):S103-4.
  18. Lowy I, et al. Treatment with monoclonal antibodies against Clostridium difficile toxins. N Engl J Med. 2010;362;3:197-205.
  19. Louie TJ, et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med. 2011;364:422-31.