Astellas Pharma EMEA

New Study Reveals the Impact of Clostridium difficile Infection (CDI) on the Health Service is Equivalent to an Additional 10,670 Bed Days a Year

Vienna (ots/PRNewswire) - CDI is one of the top ten hospital-acquired infections (HAIs) in European Hospitals[1] and is estimated to be three times as deadly as MRSA[2],[3]

Data released at the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) 2017 demonstrate the impact of CDI on the health service amounts to 10,670 bed days over a year, the equivalent to a fully occupied 30 bed ward, with each CDI case costing approximately £7,500.[4] In addition, the study conducted by the Scottish Healthcare Associated Infection Prevention Institute (SHAIPI), reveals that a sixth of patients cured of the initial CDI recur within three months and nearly one third of those have a second recurrence within a year.[4] The SHAIPI CDI study investigated the clinical outcomes following hospitalisation of patients with CDI in Scotland and consisted of two analyses; the first analysis aimed to understand the impact of the infection;[4] the second investigated clinical outcomes in community associated CDI (CA-CDI) and hospital associated CDI (HA-CDI).[5]

CDI costs healthcare services approximately EUR3 billion across Europe each year.[6] Recurrence of CDI occurs in up to 25% of patients within 30 days of initial treatment with broad-spectrum antibiotics[7],[8],[9] and patients with one recurrence have an estimated 40% risk of a further episode.[10] Recurrent CDI is associated with increased mortality rates and longer hospital stays.[11],[12] CDI is more common in those taking antibiotics, the elderly, transplant patients, those with underlying diseases and hospital patients.[13],[14],[15],[16],[17]

Professor Alistair Leanord, Consultant Microbiologist, University of Glasgow, commented, "We have seen large reductions in CDI in the UK over the last decade, however, there has been little change in the rates of recurrence and death as a result of Clostridium difficile infection. This study shows that patients with CDI, whether community or hospital associated, have a doubling of mortality, and a longer length of stay with a significant cost to the NHS. We now have a clearer understanding of the national burden of CDI in terms of recurrences, deaths, cost to the healthcare service and the increasing importance of community acquisition of infection. This will allow us to target future interventions in a more focused, cost effective manner to improve patients' care."

The study was undertaken by the universities of Glasgow, Strathclyde and Dundee, and data was analysed from 3,304 hospital cases of CDI and 9,516 controls from August 2010 to July 2013. Of the total number of CDI cases recorded, 58% came from female patients. In terms of mortality, 29% of those with CDI died within two months compared to 14% of control cases and hazard ratio of death was also found to be 2.1 times greater for CDI cases compared to controls (95% 1.9, CI 2.5). With regard to time spent in hospitals, those with CDI had an estimated additional length of stay of 9.7 days compared to controls.[4]

The second data analysis consisted of 1,297 CA-CDI cases and 3,980 controls and 2,007 HA-CDI cases and 5,536 controls. Results suggest that, compared to controls, mortality rates are higher amongst HA-CDI cases (33.0% vs 17.7%) than in CA-CDI cases (22.4% vs 9.6%). Median length of stay was 7.2 days greater than controls for CA-CDI cases and 12.0 days greater for HA-CDI cases.[5]

Professor Mark Wilcox, Professor of Medical Microbiology, Leeds Teaching Hospitals & University of Leeds, commented, "These new studies focus on the outcomes associated with CDI, including community- and hospital-associated cases. The findings, based on large groups of cases and control patients, emphasise the considerable healthcare and societal burdens of CDI. Notably there was a doubling risk of death for both community- and hospital-associated CDI cases compared with (non-CDI) control patients." He continued, "Furthermore, the lengths of hospital stay for both groups of CDI cases was about twice as long as that for controls; these add up to a substantial burden on the NHS, at a time of major service pressures. The figures mean that we must optimise efforts to prevent CDI and to treat cases optimally to reduce the risk of recurrent infections."

Reducing the threat and the burden of infectious diseases like CDI is increasingly linked to antibiotic stewardship.[18] In this context, inappropriate use of antibiotics may cause the development of antimicrobial resistance,[19] increasing risk of CDI and other medical complications.[13],[15],[20] CDI is also often treated with broad-spectrum antibiotics that further damage the 'good' bacteria, increasing the risk of the CDI returning.[10],[21] Refining and optimising the use of antibiotics in the treatment of CDI therefore has the potential to serve as an accepted practice example for antibiotic stewardship in the treatment of infectious diseases.

About Clostridium difficile infection

Clostridium difficile infection (CDI) is a recurring and preventable bacterial infection of the colon that causes severe and potentially deadly diarrhoea.[14],[15],[22] 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'.[15] 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.[14],[15] CDI is one of the top ten hospital-acquired infections (HAIs) in European hospitals[1] and is estimated to be three times as deadly as MRSA.[2],[3] 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.[23],[24] 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,[25] and occurs in up to 25% of patients within 30 days of initial treatment with broad-spectrum antibiotics.[7],[8],[9]

About Scottish Healthcare Associated Infection Prevention Institute (SHAIPI)

The Scottish Healthcare Associated Infection Prevention Institute (SHAIPI) has been set up with Scottish Government funding via the Scottish Infection Research Network (SIRN). It involves partnerships with a number of Scottish universities, NHS stakeholders and industry to develop research in the three main areas of molecular epidemiology, informatics and applied infection prevention and control to tackle the threat to public health from emergent healthcare associated infections and antimicrobial resistance, utilising rapid knowledge transfer, state of the art laboratory techniques and novel interventions.[26]

About the SHAIPI study

The SHAIPI CDI study investigated the clinical outcomes following hospitalisation of patients with CDI in Scotland. The primary analysis 'Clinical outcomes following hospitalisation with Clostridium difficile' aimed to quantify the impact of CDI on recurrence of CDI, mortality, readmissions to hospital and length of stay, in order to understand the impact of the infection.[4] The second analysis 'Clinical outcomes following community associated and hospital associated Clostridium difficile infection: matched case-control studies' investigated the recurrence of CDI and readmissions to hospital, in both community associated CDI (CA-CDI) and hospital associated CDI (HA-CDI) cases, and mortality and length of stay in CA-CDI cases compared to controls and HA-CDI cases compared to controls.[5] The research was funded by Astellas Pharma EMEA.

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. 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 2017).

2. Bauer MP, et al. Clostridium difficile infection in Europe: a hospital-based survey. Lancet. 2011;377:63-73.

3. 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 2017).

4. Data on file, AI/17/0003/APEL, Astellas Pharma Europe Ltd, April 2017.

5. Data on file, AI/17/0002/APEL, Astellas Pharma Europe Ltd, April 2017.

6. Kuijper EJ, et al. ESCMID study group for Clostridium difficile. Emergence of Clostridium difficile associated disease in North America and Europe. Clin Microbiol Infect. 2006;12:2-18.

7. Johnson S, et al. Vancomycin, Metronidazole, or Tolevamer for Clostridium difficile Infection: Results From Two Multinational, Randomized, Controlled Trials. Clin Infect Dis. 2014;59(3):345-54.

8. Lowy I, et al. Treatment with monoclonal antibodies against Clostridium difficile toxins. N Engl J Med. 2010;362;3:197-205.

9. Louie TJ, et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med. 2011;364:422-31.

10. Kelly CP, LaMont JT. Clostridium difficile - more difficult than ever. N Engl J Med. 2008;359(18):1932?1940.

11. Olsen MA, et al. Recurrent Clostridium difficile infection is associated with increased mortality. Clin Microbiol Infect. 2014;1-7.

12. Heimann SM, et al. Economic burden of Clostridium difficile associated diarrhoea: a cost-of-illness study from a German tertiary care hospital. Infection. 2015:43:707.

13. Barbut F, Petit JC. Epidemiology of Clostridium Difficile Associated Infections. Clin Microbiol Infect. 2001;7:405-10.

14. McMaster-Baxter NL, Musher DM. Clostridium difficile: recent epidemiologic findings and advances in therapy. Pharmacotherapy. 2007;27:1029-39.1.

15. Sunenshine R, McDonald L. Clostridium difficile-associated disease: new challenges from an established pathogen. Cleve Clin J Med. 2006;73:187-97.

16. Klingler PJ, et al. Clostridium difficile Infection: Risk Factors, Medical and Surgical Management. Digestive Diseases Anti-infectives. 2000:18:147-160.

17. Donnelly JP et al. Hospital-Onset Clostridium difficile Infection Among Solid Organ Transplant Recipients. J Am Transplantation. 2015:15(11):2970-2977.

18. Mamoon A. An evaluation of the impact of antibiotic stewardship on reducing the use of high-risk antibiotics and its effect on the incidence of Clostridium difficile infection in hospital settings. Journal of antimicrobial chemotherapy. 2012:67(12):2988-2996.

19. Bell BG. A systematic review and meta-analysis of the effects of antibiotic consumption on antibiotic resistance. BMC Infectious Diseases. 2014;14:13.

20. Bignardi GE. Risk factors for Clostridium difficile infection. J Hospital Infect. 1998:40:1-15.

21. Louie TJ, et al. Fidaxomicin preserves the intestinal microbiome during and after treatment of Clostridium difficile infection (CDI) and reduces both toxin reexpression and recurrence of CDI. Clinical Infectious Diseases. 2012:2:S132-142.

22. Ananthakrishnan AN. Clostridium difficile infection: epidemiology, risk factors and management. Nat Rev Gastroenterol Hepatol. 2011;8:17-26.

23. Oake N, et al. The effect of hospital acquired Clostridium difficile infection on in-hospital mortality. Arch Intern Med. 2010;1701804-10.

24. 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.

25. Bauer MP, et al. European Society of Clinical Microbiology and Infectious Disease (ESCMID): treatment guidance document for Clostridium difficile-infection (CDI). Clin Microbiol Infect. 2009;15:1067-79.

26. Scottish Healthcare Associated Infection Prevention Institute. About SHAIPI. Available from: http://www.gla.ac.uk/researchinstitutes/iii/research/researchcentres/sirn/shaipi/welcometoshaipi/ (last accessed April 2017).

April 2017

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Contact:

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jfisher@ruderfinn.co.uk
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