New Expert Report Informs Europe's Policymakers on Crucial Changes Needed to Improve the Diagnosis and Management of CDI

CHERTSEY, England, April 19, 2013 /PRNewswire/ --

Clostridium difficile infection (CDI), a potentially fatal disease, is one of the most common healthcare-associated infections^[1]

Urgent action is needed to improve the diagnosis and management of CDI, which is the main cause of hospital-acquired (nosocomial) diarrhoea in industrialised countries.^[2] In a report launched today, during a meeting hosted by the European Healthcare and Hospital Federation (HOPE), experts from across Europe highlight the current deficiencies in the management of CDI and outline the steps that are needed to address them.

To view the Multimedia News Release, please click:

http://www.multivu.com/mnr/60637-astellas-report-diagnosis-management-CDI

Hospital patients with CDI are up to three times more likely to die in hospital (or within a month of infection) than those without CDI.^[3],[4] Furthermore, CDI has an enormous impact on healthcare systems and infected patients can stay in hospital an extra 1-3 weeks^[5],[6],[7] at an additional cost of up to €14,000, compared with patients without CDI.^[8] The reported levels of CDI across Europe vary widely.^{[9],[10],[11],[12],[13]} However, failure to detect CDI cases leads to confusion about the true incidence of this HAI. A recent comprehensive incidence study was carried out in Spain, in 2010, and found that two thirds of CDI cases were undiagnosed or misdiagnosed.^[14]

The CDI in Europe Report, written by a group of leading European infectious disease experts with the support of Astellas Pharma Europe Ltd., demonstrates how CDI threatens patient safety and the quality of care provided. The Report makes recommendations to improve CDI management, within the context of current EU policy initiatives, which call for increased awareness of the signs and symptoms of CDI to improve rates of testing and diagnosis as well as improved awareness of and compliance with guidelines for CDI therapy and infection control. The Report also makes a case for the introduction of national-level surveillance systems in all Member States and increased patient education and awareness.

"It's vital that governments see CDI management as a key indicator of patient safety and quality of care, and ensure that robust systems are in place to address it," comments Professor Mark Wilcox, Professor of Medical Microbiology at the University of Leeds and one of the CDI in Europe Report authors. "CDI is a problem in hospitals and nursing homes and can be a major drain on healthcare resources. I believe implementation of the recommendations made in this Report will help improve the recognition of CDI and subsequently lead to a reduction in its incidence and impact on patients' lives."

The Report identifies a number of reasons why CDI is not being well managed. In many countries there is an inadequate level of awareness of CDI among doctors and other healthcare workers, resulting in under-diagnosis. Where this happens treatment is delayed or omitted, leading to increased morbidity and complications in the treatment of co-existing diseases. Proactive infection control measures may also be delayed, risking further outbreaks. Additionally, only a third of European countries have a nationally recommended diagnostic test algorithm for CDI,^[15] with testing in nursing homes and the community being particularly limited.      

"We welcome this Report and its recommendations to improve the management of patients with CDI," says Pascal Garel, Chief Executive of the European Hospital and Healthcare Federation (HOPE). "Healthcare-associated infections, especially CDI - a prominent infection in Europe, are of paramount concern to hospitals. We have solutions and good practices - the goal now is to increase our efforts to promote them across Europe to address HAIs and reduce their burden on European hospitals and patients."

A full copy of the Report and its recommendations are available from http://www.epgonline.org/anti-infectives-knowledge-network/index.cfm.

NOTES FOR EDITORS

The authors of 'The CDI in Europe' Report are focused on driving change at a policy level with the aim to translate research on CDI into meaningful policy responses to help; raise awareness of CDI, improve and standardise microbiological surveillance and testing, promote a better standard of care for CDI management across Europe (including diagnostic testing, therapy, and infection control and prevention) and ultimately to improve patient outcomes.

This effort is not intended to duplicate the important projects of the European Centre for Disease Prevention and Control (ECDC), i.e. the ECDC-funded European CDI Surveillance Network (ECDIS-Net) project, and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID), but rather to supplement the work taking place in academic circles and further the reach of the outputs from these and other important initiatives.

About Clostridium difficile Infection (CDI)

CDI is a serious illness resulting from infection of the internal lining of the colon by C. difficile bacteria. The bacteria produce toxins that cause inflammation of the colon, diarrhoea and, in some cases, death.^[16] Patients typically develop CDI after the use of broad-spectrum antibiotics that disrupt normal bowel flora, allowing C. difficile bacteria to flourish.^[16],[17] The risk of CDI and disease recurrence is particularly high in patients aged 65 years and older.^[18] Recurrence of CDI occurs in up to 25% of patients within 30 days of initial treatment with current therapies.^{[19],[20],[21]} The ESCMID has identified recurrence as being the most important problem in the treatment of CDI.^[22]

About HOPE

HOPE, the European Hospital and Healthcare Federation, is an international non-profit organisation, created in 1966. HOPE represents national public and private hospital associations and hospital owners, either federations of local and regional authorities or national health services. Today, HOPE is made up of 34 organisations coming from the 27 Member States of the European Union, Switzerland and the Republic of Serbia. HOPE mission is to promote improvements in the health of citizens throughout Europe, high standard of hospital care and to foster efficiency with humanity in the organisation and operation of hospital and healthcare services. For more information about HOPE, please visit http://www.hope.be/.

About Astellas Pharma Europe Ltd.

Astellas Pharma Europe Ltd., located in the UK, is the European headquarters 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 is committed to becoming a global company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. Astellas Pharma Europe Ltd. is responsible for 21 affiliate offices located across Europe, the Middle East and Africa, an R&D site and three manufacturing plants. The company employs approximately 4,300 staff across these regions. For more information about Astellas Pharma Europe Ltd., please visit http://www.astellas.eu/.

References

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

[2] Crobach MJ, et al. European Society of Clinical Microbiology and Infectious Diseases (ESCMID): Data review and recommendations for diagnosing Clostridium difficile-infection (CDI). Clinical Microbiology and Infection 2009;15:1053-1066.

[3] Oake N, et al. The effect of hospital-acquired Clostridium difficile infection on in-hospital mortality. Arch Intern Med 2010;170:1804-10.

[4] 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.

[5] Vonberg RP, et al. Costs of nosocomial Clostridium difficile-associated diarrhoea. J Hosp Infect. 2008;70:15-20.

[6] Wilcox MH, et al. Financial burden of hospital-acquired Clostridium difficile infection. J Hosp Infect. 1996;34:23-30.

[7] Dubberke MD, Wertheimer AI. Review of current literature on the economic burden of Clostridium difficile infection. Infect Control Hosp Epidemiol. 2009;30:57-66.

[8] 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.

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

[10] Lyytikäinen O, et al. Hospitalizations and Deaths Associated with Clostridium difficile Infection, Finland, 1996-2004. Emerging Infectious Diseases.2009;15:761-5.

[11] Søes L, et al. The emergence of Clostridium difficile PCR ribotype 027 in Denmark - a possible link with the increased consumption of fluoroquinolones and cephalosporins? Euro Surveillance. 2009;14:19176.

[12] Soler P, Nogareda F, Cano R. Rates of Clostridium difficile infection in patients discharged from Spanish Hospitals, 1997-2005. Infection Control and Hospital Epidemiology. 2008;29:887-9.

[13] Vonberg RP, Schwab F, Gastmeier P. Clostridium difficile in discharged inpatients, Germany. Emerging Infectious Diseases. 2007;13:179-80.

[14] Alcala L, et al. The Undiagnosed cases of Clostridium difficile in a whole nation: where is the problem? CMI 2012;18(7):E204-13.

[15] Notermans DW, et al. Enhancing laboratory capacity for Clostridium difficile detection in Europe (Abstract P2286). Clin Micro Infect 2012;18 Suppl s3: 671.

[16] Poutanen SM, et al. Clostridium difficile-associated diarrhoea in adults. CMAJ. 2004;171:51-8.

[17] Kelly CP, et al. Clostridium difficile infection. Ann Rev Med. 1998;49:375-390.

[18] Pepin J, et al. Increasing risk of relapse after treatment of Clostridium difficile colitis in Quebec, Canada. Clin Infect Dis. 2005;40:1591-7.

[19] 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.

[20] Lowy I, et al. Treatment with Monoclonal Antibodies against Clostridium difficile Toxins. N Engl J Med. 2010;362;3:197-205.

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

[22] 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.

Video: http://www.multivu.com/mnr/60637-astellas-report-diagnosis-management-CDI