New Study Reveals European Guidelines for Clostridium difficile Infection Testing are not Routinely Being Followed[1]

CHERTSEY, England, October 19, 2012 /PRNewswire/ --

Inadequate testing may mean one of the most common healthcare-acquired infections could go undiagnosed^[2]

New data presented at the international ID Week 2012 conference in San Diego showed that over three quarters (78%) of healthcare professionals surveyed in Europe believed that they may not be following guidelines for the testing of Clostridium difficile infection (CDI).^[1] This is despite survey respondents believing that CDI is increasing with a large number of cases going undiagnosed.^[1]

CDI is one of the most common healthcare-acquired infections in Europe and the leading cause of antibiotic-associated diarrhoea in adults.^[2] CDI has become an increasing problem in hospitals, nursing homes and other long-term care facilities.^[3] It is estimated that as many as one in 50 people with CDI will die within three months as a result of the infection.^[4]

Current European Society of Clinical Microbiology and Infectious Diseases (ESCMID) guidelines recommend a two-step approach for the diagnosis of CDI involving two different tests detecting both the presence of Clostridium difficile bacteria and the toxins produced by the bacterium.^[5] Just 22% of surveyed healthcare professionals understand that their laboratories regularly used a two-test diagnostic algorithm for CDI that detects both the presence of C. difficile and the presence of toxins.^[1]

"It's concerning to see that there appears to be confusion about which CDI tests are actually being used. The findings suggest that the recommended CDI diagnostic tests may not be being conducted systematically across Europe. This could lead to under-diagnosis or misdiagnosis, ultimately meaning that patients may not receive optimum care", said Professor Mark Wilcox, Professor of Medical Microbiology, Leeds Teaching Hospitals & University of Leeds. "The net effect of this non-standardised approach to testing could also mean that the true incidence of CDI across Europe is underestimated."

The survey was conducted by GFK and commissioned by Astellas Pharma Europe Ltd. A total of 868 questionnaires were completed by healthcare professionals from France, Germany, Italy, Spain and the UK that included hospital physicians, infectious disease specialists, surgeons, primary care physicians and microbiologists.^[1]

Discrepancies between perception and reality

The survey found important discrepancies between the tests requested by physicians and those actually performed in the laboratories. While 64% of physicians requested a stool culture, only 42% of microbiologists reported using this method in the laboratory.^[1] Conversely, 44% of physicians requested an enzyme immunoassays (EIA) toxin A+B+ test, while 75% of microbiologists used these tests in the laboratory.^[1] This discrepancy may be due to the fact that stool cultures can be labour intensive and slow^[2] when EIA tests are simple and quick to perform. However, EIA tests are less sensitive^[5] and may lead to cases being undiagnosed if used alone.

"These findings reveal important variations in knowledge regarding CDI diagnosis among healthcare professionals and suggest that a significant educational effort is required to address this", said Professor Wilcox. "Physicians need to familiarise themselves with locally available tests and establish a dialogue with laboratories to optimise their diagnostic approach."

The results of this pan-European survey highlight the need to standardise testing in line with recommendations to minimise the under-diagnosis of this distressing and sometimes life-threatening infection.^[5],[6]

-Ends -

NOTES TO EDITORS:

About the survey

The survey was conducted by GFK and commissioned by Astellas Pharma Europe Ltd. Practicing clinicians and microbiologists from France, Germany, Italy, Spain and the UK, were invited to participate in an on-line survey of 33 questions. 868 questionnaires were completed: 707/868 (81%) by hospital physicians (4% microbiologists, 16% infectious diseases specialists, 62% other) and 161 (19%) by GPs.^[1]

About Clostridium difficile Infection

Clostridium difficile infection (CDI) is a serious illness resulting from infection of the internal lining of the colon by C. difficile bacteria.^[7] The bacteria produce toxins that cause inflammation of the colon, diarrhoea and, in some cases, death.^[7] Patients typically develop CDI after the use of broad-spectrum antibiotics that can reduce the number of 'good' bacteria, allowing C. difficile to multiply and to produce toxins.^[7],[8]

The risk of CDI is increased in people over the age of 65 years, in those using broad spectrum antibiotics and in patients who have a prolonged period of hospitalisation.^{[9],[10],[11]}However the true extent of CDI in Europe is unknown due to international differences in surveillance, testing and disease awareness.^[12]

The risk of CDI and disease recurrence is particularly high in patients aged 65 years and older.^[13]Recurrence of CDI occurs in up to 25% of patients within 30 days of initial treatment with current therapies.^{[14],[15],[16]} The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) has identified recurrence as being the most important problem in the treatment of CDI.^[6]

CDI also results in substantial costs to healthcare systems, in particular because of extended hospitalisation.^[17] Patients with CDI stay in hospital for one to three weeks^{[18],[19],[20]}longer and have €7,147 higher adjusted hospital costs compared with those without CDI.^[18]

About Astellas Pharma Europe

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 4,200 staff across these regions. For more information about Astellas Pharma Europe, please visit http://www.astellas.eu.

References

1. Wilcox M, et al. Management of Clostridium difficile infection (CDI). Results from a pan-European survey: perceptions and reality. Poster presented at ID Week 2012, San Diego, USA. Poster number 306.

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

3. McMaster-Baxter NL, et al. Clostridium difficile: recent epidemiologic findings and advances in therapy. Pharmacotherapy. 2007;27:1029-39.

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

5. Crobach MJ, et al. European Society of Clinical Microbiology and Infectious Diseases (ESCMID): data review and recommendations for diagnosing Clostridium difficile-infection (CDI). Clin Microbiol Infect. 2009;15:1053-66.

6. 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.

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

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

9. Bartlett JG. Historical Perspectives on Studies of Clostridium difficile and C. difficile Infection. Clinical Infectious Diseases. 2008;46:S4-11.

10. Bignardi GE. Risk factors for Clostridium difficile infection. Journal of Hospital Infection. 1998;40:1-15.

11. Barbut F, et al. Epidemiology of Clostridium Difficile Associated Infections. Clin Microbiol Infect. 2001;7:405-10.

12. Freeman J, et al. The changing epidemiology of Clostridium difficile infections. Clin Microbiol Rev. 2010;23:529-49

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

14. 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.

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

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

17. Ghantoji SS, et al. Economic healthcare costs of Clostridium difficile infection: a systematic review. J Hosp Infect. 2010;74:309-18.

18. Vonberg R, et al. Costs of nosocomial Clostridium difficile-associated diarrhoea. J Hosp Infect. 2008;70:15-20

19. Wilcox M, et al. Financial burden of hospital-acquired Clostridium difficile infection. J Hosp Infect. 1996;34:23-3020.

20. Dubberke E, et al. Review of current literature on the economic burden of Clostridium difficile infection. Infect Control Hosp Epidemiol. 2009;30:57-66