Largest Ever Study of Clostridium Difficile Infection to Attempt to Reveal True Incidence Of Disease

  Largest Ever Study of Clostridium Difficile Infection to Attempt to Reveal
                          True Incidence Of Disease

  PR Newswire

  CHERTSEY, England, December 3, 2012

CHERTSEY, England, December 3, 2012 /PRNewswire/ --

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

Today marks the launch of the EU ropean, multi-centre, prospective bi-annual
point prevalence study of CL ostridium difficile  I nfection in hospitalised
patients with D iarrhoea (EUCLID), the largest study of the prevalence of CDI
ever conducted in Europe. For the first time experts will get a clear picture
of the true incidence of CDI; a significant cause of morbidity and mortality
and a condition that is thought to be widely under-estimated. ^[2] ^, ^[3]

CDI is the leading cause of infectious diarrhoea in industrialised countries
^[4] and is estimated to kill one in 50 patients affected. ^[3] CDI
represents a huge economic burden, ^[5] patients who develop CDI stay in
hospital an extra 1-3 weeks ^[5] ^, ^[6] ^, ^[7] at an estimated additional
cost of €7,147 ^[5] compared to those without CDI. The incidence and severity
of CDI continues to increase. ^[3] ^, ^[8] ^, ^[9] ^, ^[10] ^, ^[11] The most
recent large-scale prevalence study was carried out in Spain in 2008 and
looked at the number of CDI cases within the general population at a certain
time. Results revealed that two thirds of cases of CDI were either not picked
up or were misdiagnosed within the hospital due to low clinical awareness of
CDI. ^[2]

The EUCLID study, which involves 20 European countries and approximately 500
hospitals, aims to identify the underlying incidence of CDI in hospitalised
patients with diarrhoea and highlight the extent of under-testing and
under-diagnosis per country. The study was initiated and sponsored by Astellas
Pharma Europe Ltd and endorsed by the European Society of Clinical
Microbiology and Infectious Diseases study group for Clostridium  difficile
(ESGCD).

"This study represents an important step forward in understanding the true
incidence of CDI and will provide us with much needed information about the
epidemiology of a debilitating disease in Europe," said Dr Ed Kuijper,
Chairman of the ESCMID study group for Clostridium difficile . 

The EUCLID study will be coordinated out of University of Leeds andLeeds
Teaching Hospitals NHS Trust, UK, under Professor Mark Wilcox, with support
from the EUCLID Core Group. The study is funded by Astellas Pharma Europe Ltd.
In each of the participating 20 countries, hospitals will submit samples of
all un-formed faeces received on a specified day to a national coordinating
laboratory where they will be tested for CDI using a standardised protocol.
The sampling will be performed at two different time points in the year to
reflect seasonal variations in CDI which peaks during the winter months. ^[12]
Data will also be collected on any diagnostic CDI test(s) requested within
the hospital for each sample submitted and if so, the test used and the
result. These data, along with reported CDI rates from the previous year, will
be used to calculate the level of under-recognition and under-diagnosis.

A full report and analysis of the findings will be published at the end of the
EUCLID study which is anticipated in mid-2013.

Notes to Editors:

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. ^[13]
Patients typically develop CDI after the use of broad-spectrum antibiotics
that disrupt normal bowel flora, allowing C.  difficile bacteria to
flourish. ^[13] ^, ^[14] The risk of CDI and disease recurrence is
particularly high in patients aged 65 years and older. ^[15] Recurrence of CDI
occurs in up to 25% of patients within 30 days of initial treatment with
current therapies. ^[16] ^, ^[17] ^, ^[18] ESCMID has identified recurrence
as being the most important problem in the treatment of CDI. ^[19] CDI
represents a huge economic burden, ^[5] patients who develop CDI stay in
hospital an extra1-3 weeks ^[5] ^, ^[6] ^, ^[7] at an estimated additional
cost of €7,147 ^[5] compared to those without CDI.

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, please visit
http://www.astellas.eu .

References

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factors and management. Nat Rev Gastroenterol Hepatol . 2011;8:17-26.

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

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

4. 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.

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diarrhoea. J Hosp Infect . 2008;70:15-20.

6. Wilcox MH, et al. Financial burden of hospital-acquired Clostridium
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8. Lyytikäinen O, et al. Hospitalizations and Deaths Associated with
Clostridium difficile Infection, Finland, 1996-2004. Emerging Infectious
Diseases . 2009;15:761-5.

9. 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.

10. 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.

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

12. Polgreen PM, et al. A time-series analysis of Clostridium difficile and
its seasonal association with influenza. Infect Control Hosp Epidemiol .
2010;31(4):382-7.

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

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

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

16. 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.

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

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

19. 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.

Contact: For further information please contact: Abi Dewberry, Ruder Finn,
adewberry@ruderfinn.co.uk, Tel: +44(0)20-7438-3051; Mindy Dooa, Astellas
Pharma Europe Ltd, mindy.dooa@eu.astellas.com, Tel: +44(0)1784-419-444