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Largest EU Prevalence Study of Clostridium Difficile Infection Reveals That More Than One Fifth of Patients May Receive Wrong



 Largest EU Prevalence Study of Clostridium Difficile Infection Reveals That
         More Than One Fifth of Patients May Receive Wrong Diagnosis

  PR Newswire

  BERLIN, Germany, April 27, 2013

BERLIN, Germany, April 27, 2013 /PRNewswire/ --

C lostridium difficile infection (CDI) ,   a potentially fatal disease ,   is
one of the most common healthcare acquired infections ^[1] ,   at least twice
            as common as MRSA infections in hospitals ^[2] ^, ^[3]

First results from EUCLID, the largest ever prevalence study of CDI across
Europe, were presented today at the 23 ^rd European Congress of Clinical
Microbiology and Infectious Disease (ECCMID). Data reveal that an incorrect
diagnosis may be made for more than one in five hospitalised patients with
diarrhoea, who could have CDI. ^[4] This potentially may lead to inappropriate
or inadequate treatment. ^[ ^4 ^] CDI can be severe and 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. ^[5] ^, ^[6]

The EU ropean multi-centre, prospective bi-annual point prevalence study of CL
ostridium difficile   I nfection in hospitalised patients with D iarrhoea
(EUCLID) involved 482 hospitals from 20 European countries. In total 3,920
faecal samples were submitted by participating hospitals to the EUCLID
National Coordinating laboratory (NCLs). Nearly one in four (24.6%) samples
found to be positive for C. difficile at the NCL had not been tested at the
local hospital level and 47 (2.3%) patients found to be positive for C.
difficile at the NCL were tested at the hospital but received an incorrect
negative result. Notably, only 10.6% of hospitals tested all diarrhoeal faecal
in-patient samples, and only 27.4% used an optimised CDI algorithm for routine
testing. ^[ ^4 ^]

"In this study we saw that on one day alone, 82 patients with CDI were not
diagnosed due to a lack of laboratory testing or clinical suspicion, and in
total 246 patients received an incorrect result", said Professor Mark Wilcox,
Professor of Medical Microbiology, Leeds Teaching Hospitals & University of
Leeds. "These results show that there is still more to be done to improve the
way CDI is currently being tested in hospitals across Europe."

The EUCLID study is being coordinated out of the University of Leeds, UK, by
Professor Mark Wilcox's research group, with support from the EUCLID Core
Group. The study is funded by Astellas Pharma Europe Ltd. Participating
hospitals submitted samples of all un-formed faeces received on a single day
to the NCL regardless of whether they had been tested within the hospital.
Each NCL then tested all samples using a 2-stage CDI algorithm, with the
results from the hospital and NCL then compared for each sample. ^[ ^4 ^]

In this study, the average incidence rate of CDI across Europe was 6.6 per
10,000 patient bed days. ^[ ^4 ^] This is substantially higher than a previous
pan-European surveillance study, the European Clostridium Infection Survey
(ECDIS) performed in 2008-2009 which found an average incidence rate of 4.1
per 10,000 patient bed days. ^[7] There were also wide discrepancies between
the numbers of samples tested for C. difficile within hospitals; the highest
rate of 97% of samples tested was found in the Czech Republic with the lowest
of 0% in Bulgaria. ^[ ^4 ^] Surprisingly hospitals in the UK only tested 75%
of samples despite national guidance to test all unformed stools from
inpatients. ^[ ^4 ^]

"CDI is an important patient safety issue and also creates a significant
economic burden for hospitals and health systems", comments Professor Mark
Wilcox. "It is important that optimal methods of diagnosis are in place, as
errors may lead to inappropriate or inadequate treatment of patients and
inadequate infection control measures."

A second sampling and testing wave will take place during the Summer of 2013
with the full results and analysis expected to be available in 2014.

About   Clostridium difficile     Infection

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. ^[8] Patients
typically develop CDI after the use of broad-spectrum antibiotics that disrupt
normal bowel flora, allowing C. difficile bacteria to flourish. ^[ ^8 ^] ^,
^[9] CDI is the leading cause of hospital acquired (nosocomial) diarrhoea in
industrialised countries ^[10] and the risk of CDI and disease recurrence is
particularly high in patients aged 65 years and older. ^[11] Recurrence of CDI
occurs in up to 25% of patients within 30 days of initial treatment with
current therapies. ^[12] ^, ^[13] ^, ^[14] The ESCMID has identified
recurrence as being the most important problem in the treatment of CDI. ^[15]

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. As a global company,
Astellas is committed to combining outstanding research and development (R&D)
and marketing capabilities to continue to grow in the world pharmaceutical
market. Astellas Pharma Europe Ltd. manages 21 affiliate offices located
across Europe, the Middle East and Africa.  In addition, the Company has an
R&D site and three manufacturing plants in Europe. The company employs
approximately 4,300 staff across these regions. For more information about
Astellas Pharma Europe, 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. UK Health Protection Agency. English national point prevalence survey on
healthcare-associated infections and antimicrobial use, 2011: preliminary
data. London; Health Protection Agency, 2012.

3. Meyer E, Gastmeier P, Weizel-Kage D,  et al . Associations between
nosocomial meticillin-resistant Staphylococcus aureus and nosocomial
Clostridium difficile -associated diarrhoea in 89 German hospitals. J Hosp
Infect 2012;82:181-6.

4. Davies K et al . First report from European, multi-centre, prospective
bi-annual point prevalence study of Clostridium difficile Infection in
hospitalised patients with Diarrhoea (EUCLID). Late breaker poster LB-2968
presented at European Congress of Clinical Microbiology and Infectious
Diseases (ECCMID); Berlin, Germany, 27 - 30 Apr 2013.

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

6. 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.

7. Bauer et al . Clostridium difficile infection in Europe: a hospital-based
survey. Lancet 2011 Jan 1;377(9759(:63-73).

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

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

10. 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.

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

12. 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.

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

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

15. 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: Katy Compton-Bishop, Ruder
Finn, kcompton-bishop@ruderfinn.co.uk, Tel: +44-(0)20-7438 -3069. Mindy Dooa,
Astellas Pharma Europe Ltd., mindy.dooa@eu.astellas.com, Tel:
+44-(0)7826-912-339
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